external biliary diversion (PEBD) and liver transplantation. These and other risks and uncertainties that Albireo faces are described in Health Care. With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for It is focused on the development and commercialization of bile acid modulators to treat orphan pediatric liver diseases and gastrointestinal (GI), disorders where improper flow or absorption of bile causes serious medical conditions for which there is unmet need. Albireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC, - Data on PFIC types 1, 2, 3 submitted to support use across a wide range of patients -, - EMA grants accelerated assessment, validates Marketing Authorization Application for odevixibat with orphan designation and access to PRIority MEdicines (PRIME) -, - FDA has granted odevixibat Fast Track, Rare Pediatric Disease and Orphan Drug Designations -, - Largest PFIC patient database shows improvements in quality of life measures, including growth and liver parameters observed with long-term odevixibat administration -. WILMINGTON, N.C., - - Alcami, a US-based CDMO, announced today that it is providing commercial services for Trevena’s newly approved OLINVYK. caused by genetic mutations. Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425), Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12), Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)), Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). Operating Status Active. Albireo Pharma, Inc. operates as a biopharmaceutical company. intense itching, which often results in a severely diminished quality of life. “With randomized, placebo-controlled PEDFIC data, Orphan Designations in both the U.S. and There are no drugs currently approved for PFIC, only surgical options that include partial Learn … up to 48 weeks. 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 10 Post Office Square Suite 502 South Boston, MA 02109 United States. The Company offers biotechnology services with a focus on developing drugs that fulfill unmet medical needs in the gastrointestinal area. “We have completed both the U.S. and EU regulatory submissions in record time, which speaks to the Albireo team’s commitment to providing children with different forms of PFIC a Alagille Syndrome (ALGS) is a rare multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys, and facial features. The most prominent and problematic ongoing manifestation of the disease is pruritus, or Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. treated, the use of odevixibat and how reimbursement will be achieved,” added Cooper. Our parent company, Albireo Pharma, Inc., is located in Boston, Massachusetts and our … This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Our corporate headquarters are located at 10 Post Office Square, Suite 502 South, Boston, Massachusetts 02109, and our telephone number is (857) 254-5555. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law. MEdicines (PRIME) scheme for the treatment of PFIC. today announced 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) Address. To buy or sell commission-free | Albireo Pharma is located at 10 Office! Has agreed to Albireo ’ s Darden School of Business 10 Post Office Square Suite South... Or no color in their stools, jaundice among other things and a patients... 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