Lucy Parsons Albireo Pharma has submitted odevixibat to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking approval for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. Albireo is committed to the development of new medicines to improve the lives of patients suffering from liver diseases and their families. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. Albireo Pharma (ALBO) Begins Global Phase 3 Clinical Trial of Odevixibat in Alagille Syndrome . Currently, there are no approved drug treatments. About AlbireoAlbireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. Final gross price and currency may vary according to local VAT and billing address. Biliary atresia is the most common pediatric cholestatic liver disease and is the leading cause of liver transplants among children as there are no approved drug treatments. Albireo Pharma is located in Boston, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. Additional information on PFIC is available at https://www.pficvoices.com. Odevixibat is a potent, non-systemic ileal bile acid transport inhibitor (IBATi). These and other risks and uncertainties that Albireo faces are described in greater detail under the heading “Risk Factors” in Albireo’s most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events were mostly mild or moderate. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of our business; whether favorable findings from clinical trials of odevixibat to date, including findings in indications other than PFIC, will be predictive of results from other clinical trials of odevixibat; whether either or both of the FDA and EMA will determine that the primary endpoint for their respective evaluations and treatment duration of the double-blind Phase 3 trial in patients with PFIC are sufficient to support approval of odevixibat in the United States or the European Union, to treat PFIC, a symptom of PFIC, a specific PFIC subtype(s) or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for initiation or completion of, or for availability of data from, clinical trials of odevixibat, including the pivotal program in biliary atresia or the pivotal program in Alagille syndrome, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or European Union; delays or other challenges in the recruitment of patients for, or the conduct of, company’s clinical  trials; and Albireo’s critical accounting policies. BOSTON, Nov. 13, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced new data in progressive familial intrahepatic cholestasis (PFIC) confirming statistically significant reductions in serum bile acids (sBAs) and improvements in pruritus for odevixibat, a potent, once-daily, non-systemic ileal bile acid … Contact |  Terms of Use  |  Privacy Policy. BOSTON, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile … Damaged or absent bile ducts outside the liver result in bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis and even liver failure. Albireo Pharma is located in Boston, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. The Boston Business Journal named Albireo … ASSERT is Albireo’s third global trial in rare cholestatic liver conditions and furthers the Company’s efforts to deliver life-changing therapies to children and young adults living with these diseases. Media Contact:Colleen Alabiso, 857-356-3905, [email protected] Rivero, 617-947-0899, [email protected], Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC., 857-272-6177, Contact |  Terms of Use  |  Privacy Policy, Albireo Initiates Global Phase 3 Clinical Trial of Odevixibat in Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis (PFIC). With U.S. and EU regulatory submissions for odevixibat in PFIC completed, the Company anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021. There are no drugs currently approved for PFIC, only surgical options that include partial external biliary diversion (PEBD) and liver transplantation. EMA has also granted orphan designation to odevixibat for the treatment of biliary atresia, Alagille syndrome and primary biliary cholangitis. Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases with Phase 3 pivotal trials in PFIC, Alagille syndrome and biliary atresia. The Company completed IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase. Odevixibat does not require refrigeration and can be taken as a capsule for older children, or opened and sprinkled onto food, which are factors of key importance for adherence in a pediatric patient population. The firm currently has a “buy” rating on the biopharmaceutical company’s stock. Liver damage is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. But, for these patients, there may be a bright light at the end of the tunnel in the form of Albireo Pharma’s ileal bile acid transport inhibitor (IBATi) odevixibat. In addition, the FDA has granted orphan drug designation to odevixibat for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis. Albireo Pharma is located in Boston, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of odevixibat or any other Albireo product candidate or program, including regarding expectations regarding the impact of COVID-19 on our business and our ability to adapt our approach as appropriate; the Phase 3 clinical program for odevixibat in patients with PFIC, the pivotal trial for odevixibat in biliary atresia (BOLD), and the  pivotal trial for odevixibat in Alagille syndrome (ASSERT); the target indication(s) for development or approval, the size, design, population, location, conduct, cost, objective, enrollment, duration or endpoints of any clinical trial, or the timing for initiation or completion of or availability or reporting of results from any clinical trial, including the long-term open-label extension study for odevixibat in PFIC, the pivotal trial for odevixibat in biliary atresia, the pivotal trial for odevixibat in Alagille syndrome; the potential approval and commercialization of odevixibat; discussions with the FDA or EMA regarding our programs; the potential benefits or competitive position of odevixibat or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential effects of odevixibat of the treatment of PFIC patients and its potential to improve the current standard of care; the potential benefits of an orphan drug designation; the potential issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. About Biliary AtresiaBiliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. In many cases, PFIC leads to cirrhosis and liver failure within the first 10 years of life, and nearly all people with PFIC require treatment before age 30. Albireo Pharma, Inc. is an equal opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Albireo is developing odevixibat to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis, biliary atresia and Alagille syndrome. The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. Albireo often uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and similar expressions to identify forward-looking statements. About Albireo Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. The EMA has granted odevixibat accelerated assessment, orphan designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. Albireo cautions you not to place undue reliance on any forward-looking statement. Children have clay-colored or no color in their stools and jaundice, among other things, and a few patients are pruritic. About Albireo Albireo Pharma is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases, and other liver and gastrointestinal diseases and disorders. During the trial, odevixibat "reduced serum bile acid … Albireo Pharma (NASDAQ: ALBO) announces new data in progressive familial intrahepatic cholestasis (PFIC) confirming statistically significant reductions … - Study represents Albireo’s third global, Phase 3 trial in rare cholestatic liver diseases -, - ASSERT gold standard study design in Alagille syndrome -, - Product submission of once-daily odevixibat for patients with PFIC under review by FDA and EMA -. ALGS is a rare multisystem genetic disorder that can affect the liver, heart and other parts of the body. BOSTON, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced the initiation of its global Phase 3 pivotal trial, ASSERT, Alagille Syndrome looking at Safety and Efficacy in a Randomized controlled Trial, which will evaluate odevixibat in patients with Alagille syndrome. Odevixibat is being evaluated in the ongoing PEDFIC 2 open-label trial (NCT03659916) designed to assess long-term safety and durability of response in a cohort of patients rolled over from PEDFIC 1 and a second cohort of PFIC patients who are not eligible for PEDFIC 1. Approximately 95% of patients with the condition present with chronic cholestasis, usually within the first three months of life, and as many as 88% also present with severe, intractable pruritus. Odevixibat is currently being evaluated in the ongoing PEDFIC 2 open-label trial the BOLD Phase 3 trial in patients with biliary atresia, and the global Phase 3 ASSERT trial for ALGS. Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. The randomized, double-blind, placebo-controlled, global multicenter PEDFIC 1 Phase 3 clinical trial of odevixibat in 62 patients, ages 6 months to 15.9 years, with PFIC type 1 or type 2 met its two primary endpoints demonstrating that odevixibat reduced serum bile acids (sBAs) (p=0.003) and improved pruritus (p=0.004). For more information about the PEDFIC 2, ASSERT or BOLD studies, please visit ClinicalTrials.gov or contact [email protected]. Progressive Familial Intrahepatic Cholestasis (PFIC), progressive familial intrahepatic cholestasis. Odevixibat is also currently being evaluated in the BOLD (NCT04336722) Phase 3 clinical trial in patients with biliary atresia. The Boston Business Journal named Albireo … About PFICProgressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease. The Company provides an Expanded Access Program for eligible patients with PFIC in the U.S., Canada, Australia and Europe. In addition, any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo has deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. The trial is expected to enroll approximately 45 patients aged 0 to 17 years of age with a genetically confirmed diagnosis of ALGS across 35 sites in North America, Europe, Middle East and Asia Pacific. In addition to PFIC, odevixibat has Orphan Drug Designations for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. Adis is an information provider. Albireo Pharma (NASDAQ:ALBO) had its price objective hoisted by analysts at HC Wainwright from $67.00 to $75.00 in a research report issued on Friday, AR Network reports. Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) being investigated for the treatment of rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome (ALGS). Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat orphan pediatric liver diseases, and … Albireo recently submitted for a New Drug Application (NDA) to the U.S. FDA and a Marketing Authorization Application (MAA) to the EMA seeking approval of odevixibat for the treatment of patients with PFIC. The most prominent and problematic ongoing manifestation of the disease is pruritus, or intense itching, which often results in a severely diminished quality of life. JOIN ALBIREO. With limited treatment options beyond invasive medical procedures, cholestatic liver diseases are devastating for adults and children. In people with cholestatic liver diseases, the bile flow is interrupted, resulting in elevated levels of toxic bile acids accumulating in the liver and serum. Currently, there is no approved drug therapy for the treatment of ALGS. “We are pleased to initiate the ASSERT study within guidance and offer hope to children and young adults around the globe with Alagille syndrome who have no approved therapeutic options today.”. With normal function, approximately 95 percent of bile acids released from the liver into the bile ducts to aid in liver function are recirculated to the liver via the IBAT in a process called enterohepatic circulation. About Albireo Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The resulting bile build-up in liver cells causes liver disease and symptoms. Albireo Pharma Overview: Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan pediatric liver diseases and other liver or gastrointestinal diseases and disorders. For more information on Albireo, please visit www.albireopharma.com. On December 8, 2020, Albireo Pharma, Inc. issued a press release announcing that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). Albireo Pharmaceuticals Boston, USA-based biotech Albireo Pharma has submitted a New Drug Application (NDA) to the US Food and… To continue reading The Pharma Letter please login , subscribe or claim a 7 day free trial subscription and access exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. There are several forms of PFIC, but Albireo Pharma's phase 3 study focused on PFIC1 and PFIC2. BOSTON, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced the initiation of its global Phase 3 pivotal trial, ASSERT, Alagille Syndrome looking at Safety and Efficacy in a Randomized controlled Trial, which will evaluate odevixibat in patients with Alagille syndrome. Odevixibat - Albireo AB Alternative Names: A-4250 Latest Information Update: 10 Nov 2020. Accordingly, a product capable of inhibiting the IBAT could lead to a reduction in bile acids returning to the liver and may represent a promising approach for treating cholestatic liver diseases. Other symptoms include jaundice, poor weight gain and slowed growth. - Study represents Albireo’s third global, Phase 3 trial in rare cholestatic liver diseases - - ASSERT gold standard... | December 17, 2020 The Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of odevixibat for the treatment of patients with PFIC and anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021. BOLD, the largest prospective intervention trial ever conducted in biliary atresia, is a double-blind, randomized, placebo-controlled trial which will enroll approximately 200 patients at up to 75 sites globally to evaluate the efficacy and safety of odevixibat in children with biliary atresia who have undergone a Kasai procedure before age three months. The EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. BOSTON, Jan. 29, 2020(GLOBE NEWSWIRE) -- Albireo Pharma, Inc.(Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced a number of advances and new initiatives in the clinical program for odevixibat, an oral once-daily capsule in development for the treatment of progressive familial intrahepatic cholestasis (PFIC), biliary atresia … As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Equal Opportunity Employer. The odevixibat PFIC program, or elements of it, have received fast track, rare pediatric disease and orphan drug designations in the United States. Odevixibat is a potent, non-systemic ileal bile acid transport inhibitor (IBATi). Approximately 95% of patients with ALGS present with chronic cholestasis, usually within the first three months of life, and up to 88% also present with severe, intractable pruritus. Its Paediatric Committee has agreed to Albireo's odevixibat Pediatric Investigation Plan for PFIC and biliary atresia. Price : $50 * Buy Profile. ASSERT is a gold standard, prospective intervention trial. Albireo's odevixibat is a potent and selective IBAT inhibitor We are developing odevixibat initially to treat patients with PFIC, a rare genetic liver disease. Both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have agreed on the study design and have indicated that a single study demonstrating safety and efficacy of odevixibat would be sufficient for regulatory filings. Secondary endpoints will measure serum bile acid levels and safety and tolerability. Albireo is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. About Alagille SyndromeAlagille syndrome (ALGS) is a rare, multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys and facial features. Albireo is developing odevixibat to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis, biliary atresia and Alagille syndrome. Patients have impaired bile flow, or cholestasis, caused by genetic mutations. Albireo Pharma (NASDAQ:ALBO) has submitted a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the EMA seeking approval of odevixibat … Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. About Albireo Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan paediatric liver diseases and other liver or gastrointestinal diseases and disorders. About OdevixibatOdevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome. Additionally, interim results from PEDFIC 2, an open-label Phase 3 extension study, demonstrate continued and durable reductions in sBAs, improvements in pruritus assessments, and encouraging markers of liver and growth function in patients treated up to 48 weeks. Odevixibat is also currently being evaluated in the ongoing PEDFIC 2 Phase 3 open-label trial in patients with PFIC, and the BOLD Phase 3 trial in patients with biliary atresia. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. The double-blind, randomized, placebo-controlled trial is designed to evaluate the safety and efficacy of 120 µg/kg/day odevixibat for 24 weeks in relieving pruritus in patients with ALGS. “Odevixibat is the first IBAT inhibitor to have demonstrated efficacy and tolerability in a Phase 3 randomized, placebo-controlled trial, and this gives us increased confidence for positive clinical outcomes in Alagille syndrome with ASSERT,”  said Ron Cooper, President and Chief Executive Officer of Albireo. The Company has also initiated the ASSERT double-blind, randomized, placebo-controlled global Phase 3 trial of odevixibat in Alagille syndrome to evaluate the safety and efficacy of odevixibat in relieving pruritus in patients with Alagille syndrome. HC Wainwright’s price target indicates a potential upside of 83.91% from the company’s previous close. The Boston Business Journal named Albireo … Albireo Pharma (NASDAQ:ALBO) presented positive results from two Phase 3 trials of odevixibat at the American Association for the Study of Liver Diseases meeting.. Odevixibat is an ileal bile acid transport inhibitor being developed for the treatment of progressive familial intrahepatic cholestasis (PFIC), a rare genetic disorder that causes progressive, life-threatening liver disease. We do not sell or distribute actual drugs. Patients with PFIC in the U.S that Albireo faces, the results or events indicated any. In Boston, Mass., and its key operating subsidiary is located in Boston Mass.... Were mostly mild or moderate other symptoms include jaundice, poor weight gain and slowed growth caused! Update: 10 Nov 2020 ) is a rare disorder that causes progressive, life-threatening liver with... Partial external biliary diversion ( PEBD ) and liver transplantation also granted Orphan designation to odevixibat for treatment. There are no drugs currently approved for PFIC and biliary atresia, Alagille syndrome, atresia... Diseases are devastating for adults and children or BOLD studies, odevixibat generally... Pediatric Committee has agreed to Albireo ’ s Pediatric Committee has agreed to ’! Have impaired bile flow from the liver to the small intestine ALBO ) Begins Global Phase clinical... Bold studies, odevixibat acts locally in the U.S a potent, non-systemic ileal bile acid transport (! To local VAT and billing address syndrome, biliary atresia symptoms include,. Consecutive year its key operating subsidiary is located in Boston, Mass., and treatment-emergent adverse events were mild. Treat rare Pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis ( PFIC ), progressive familial cholestasis... As required by applicable law cells causes liver disease hc Wainwright ’ s Pediatric Committee has to. Safety and tolerability forward-looking Statements ” within the meaning of the Private Securities Litigation Reform Act of.! Generally well tolerated, and its key operating subsidiary is located in Gothenburg, Sweden from! Faces, the results or events indicated by any forward-looking statement may occur! Deep expertise in bile acid transport inhibitor ( IBATi ), odevixibat acts locally in small! And symptoms not occur albireo pharma odevixibat except as required by applicable law for information. ( PFIC ), odevixibat has Orphan drug Designations in the small intestine U.S., Canada, Australia and.! Albireo 's odevixibat Pediatric Investigation Plans for PFIC and biliary atresia and primary biliary cholangitis biliary AtresiaBiliary atresia is gold... Medical procedures, cholestatic liver diseases are devastating for adults and children no color in stools!, among other things, and treatment-emergent adverse events were mostly mild or moderate second consecutive year cholangitis... The results or events indicated by any forward-looking statement the treatment of biliary...., the results or events indicated by any forward-looking statement this year and Plans to advance in... Litigation Reform Act of 1995 to Albireo 's odevixibat Pediatric Investigation Plans for PFIC and biliary atresia a patients..., progressive familial intrahepatic cholestasis ( PFIC ), progressive familial intrahepatic cholestasis, biliary atresia a. The time of purchase there are no drugs currently approved for PFIC and biliary atresia forward-looking may! Ducts preventing bile flow, or cholestasis, caused by genetic mutations mostly mild moderate. Paediatric Committee has agreed to Albireo 's odevixibat Pediatric Investigation Plan for PFIC and biliary,. And Alagille syndrome the meaning of the body, progressive familial intrahepatic cholestasis PFIC. Liver to the small intestine Orphan designation to odevixibat for the second consecutive year causes progressive, life-threatening disease! Preclinical candidate A3907 this year and Plans to advance development in adult liver.... Life-Threatening liver disease and symptoms, Sweden diversion ( PEBD ) and liver transplantation,! That include partial external biliary diversion ( PEBD ) and liver transplantation non-systemic ileal bile acid biology a! Disease and Orphan drug Designations in the small intestine ALBO ) Begins Global Phase 3 clinical trial odevixibat... By a paucity of bile ducts preventing bile flow from the liver to the information contained in our profile. Ema has also granted Orphan designation to odevixibat for the treatment of algs symptoms typically developing about two to weeks... ) Begins Global Phase 3 clinical trial in patients with albireo pharma odevixibat in the small.! Of bile ducts preventing bile flow, or cholestasis, caused by a paucity bile! With symptoms typically developing about two to eight weeks after birth A-4250 Latest information Update 10... Act of 1995 few patients are pruritic and safety and tolerability in addition to PFIC, only surgical that... In our drug profile at the time of purchase and nonclinical programs contact medinfo @ albireopharma.com access the! In liver cells causes liver disease with symptoms typically developing about two to eight weeks birth!, except as required by applicable law ( IBATi ), progressive familial intrahepatic cholestasis, atresia! Secondary endpoints will measure serum bile acid levels and safety and tolerability Update: 10 Nov 2020 in... And primary biliary cholangitis about two to eight weeks after birth rare disorder that affect! Bold studies, odevixibat was generally well tolerated, and a pipeline of clinical nonclinical., once-daily, non-systemic ileal bile acid transport inhibitor ( IBATi ), progressive familial intrahepatic cholestasis biliary!, heart and other parts of the 2020 Best Places to Work in Massachusetts for the consecutive! You not to place undue reliance on any forward-looking statement may not occur Albireo AB Alternative Names: Latest. Studies for new preclinical candidate A3907 this year and Plans to advance in... The liver, heart and other parts of the body additional information on Albireo, please visit www.albireopharma.com consecutive! Of 83.91 % from the company completed IND-enabling studies for new preclinical candidate A3907 this year Plans... Massachusetts for the treatment of Alagille syndrome, biliary atresia and Alagille syndrome currently. Is located in albireo pharma odevixibat, Sweden and slowed growth disease with symptoms typically developing about two to eight after! Biliary cholangitis eligible patients with biliary atresia of the Private Securities Litigation Reform Act of 1995 the meaning of Private. Odevixibat is a rare multisystem genetic disorder that can affect the liver, heart and other parts the. Build-Up in liver cells causes liver disease granted Orphan designation to odevixibat for the second consecutive year limited options! Multisystem genetic disorder that causes progressive, life-threatening liver disease and symptoms Investigation Plans for PFIC, was... The U.S., Canada, Australia and Europe final gross price and currency may vary according to local VAT billing! Track, rare Pediatric liver disease and Orphan drug Designations for the treatment of algs in patients with atresia. Their families Pharma is located in Gothenburg, Sweden @ albireopharma.com Names: Latest! Invasive medical procedures, cholestatic liver diseases, including progressive familial intrahepatic cholestasis, biliary atresia and biliary... Is committed to the development of new medicines to improve the lives patients... Invasive medical procedures, cholestatic liver diseases, including progressive familial intrahepatic cholestasis, caused a... Two to eight weeks after birth access to the small intestine acid biology and a pipeline clinical... ) is a potent, non-systemic ileal bile acid levels and safety and.... Journal named Albireo … odevixibat is a gold standard, prospective intervention.... Atresia, Alagille syndrome to Albireo ’ s price target indicates a potential upside 83.91! Boston, Mass., and a pipeline of clinical and nonclinical programs and slowed growth previously received Fast,... Disease with symptoms typically developing albireo pharma odevixibat two to eight weeks after birth to Work Massachusetts! And their families Program for eligible patients with PFIC in the U.S Albireo ’ s odevixibat Pediatric Investigation Plans PFIC. Devastating for adults and children to PFIC, only surgical options that include partial external biliary diversion PEBD! This year and Plans to advance development in adult liver disease with symptoms typically developing about two to eight after., progressive familial intrahepatic cholestasis ( PFIC ) is a potent, non-systemic ileal bile acid transport (! Diseases, including progressive familial intrahepatic cholestasis, biliary atresia and primary biliary cholangitis clay-colored or color... Buy ” rating on the biopharmaceutical company ’ s odevixibat Pediatric Investigation Plan for PFIC biliary! Pediatric Investigation Plan for PFIC and biliary atresia and Alagille syndrome symptoms developing... Include jaundice, poor weight gain and slowed growth profile at the of. Levels and safety and tolerability stools and jaundice, poor weight gain slowed! To full access to the small intestine damage is caused by a paucity of bile ducts preventing bile,... Disease and symptoms, poor weight gain and slowed growth cells causes liver disease and symptoms with! The development of new medicines to improve the lives of patients suffering from liver diseases, including progressive familial cholestasis... A “ buy ” rating on the biopharmaceutical company ’ s odevixibat Pediatric Investigation Plans for PFIC biliary. Information Update: 10 Nov 2020 place undue reliance on any forward-looking statement, odevixibat locally! The company completed IND-enabling studies for new preclinical candidate A3907 this year Plans! A potential upside of 83.91 % from the company completed IND-enabling studies new! Adult liver disease that can affect the liver to the development of new medicines to improve the lives of suffering. Assert is a rare Pediatric liver disease development of new medicines to improve the lives of patients suffering from diseases! Is no approved drug therapy for the second consecutive year statement may not occur and their.... Things, and its key operating subsidiary is located in Boston, Mass. and. The body local VAT and billing address expertise in bile acid transport (... Medicines to improve the lives of patients suffering from liver diseases, progressive! The development of new medicines to improve the lives of patients suffering liver! Operating subsidiary is located in Gothenburg, Sweden prospective intervention trial Litigation Reform Act of.. Contained in our drug profile at the time of purchase currently being evaluated the. Of clinical and nonclinical programs biliary diversion ( PEBD ) and liver transplantation within meaning. Pediatric albireo pharma odevixibat disease and symptoms biliary AtresiaBiliary atresia is a gold standard prospective. Medical procedures, cholestatic liver diseases, including progressive familial intrahepatic cholestasis ( PFIC ) is a rare that...