Ipsen and Medison Pharma Announce Health Canada Approval of Bylvay
Positive opinion from Committee for Medicinal Products for Human Use recommending approval of Bylvay® (odevixibat) based on Phase III ASSERT clinical-trial data in Alagille syndrome (ALGS) already...
Albireo`s Bylvay (Odevixibat) Approved In Europe
TOKYO, June 20, 2023 /PRNewswire/ -- Jadeite Medicines Inc., (Jadeite Medicines) a clinical stage biopharmaceutical company headquartered in Tokyo, Japan (President & CEO, Eiichi Takahashi) has received Orphan Drug Designation for odevixibat for the expected indication of PFIC from the Ministry of Health, Labour and Welfare (MHLW) of Japan. Jadeite Medicines has also announced initiation of a phase 3 trial in PFIC for patients in Japan. PFIC is a rare and devastating disorder affecting young children with no approved treatment in Japan.
After Ipsen made a splash at this year's J.P. Morgan Healthcare Conference by scooping up liver disease specialist Albireo Pharma, the centerpiece of the buyout, Bylvay, has won a coveted label expansion.
Six abstracts to be presented demonstrating efficacy and tolerability of investigational Bylvay in select cholestatic liver diseasesNew data emphasizes the consistent benefit of Bylvay as an...
Albireo Submits Bylvay® Alagille Syndrome Regulatory Filings to FDA and EMA
BOSTON, Nov. 30, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced that the Committee Economic Health Products (CEPS) has approved reimbursed access to Bylvay (odevixibat) in France following a favorable clinical assessment from the Haute Autorité de Santé (HAS) for the treatment of progressive familial intrahepatic cholestasis (PFIC) types 1 and 2 (except for the BSEP3 subtype). A potent, oral, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay has minimal systemic exposure and acts locally in the small intestine as a treatment for PFIC, a rare and devastating disorder that affects young children and causes progressive, life-threatening liver disease. Bylvay received from the HAS Transparency Committee an Important SMR for its medical benefit and a Moderate ASMR III for its improvement in medical benefit.
BOSTON, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, presented new data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2022, being held November 4 – 8, 2022 in Washington, D.C. Across three oral presentations, including two late-breakers, and six posters, the Company provided evidence of early, rapid, and sustained efficacy with Bylvay (odevixibat) treatment in patients with progressive familial intrahepatic cholestasis (PFIC) and Alagille syndrome (ALGS).