ALBO - Albireo receives positive CHMP opinion for Bylvay for rare liver disease

Albireo Pharma (ALBO) announces that the EMA's Committee for Medicinal Products for Human Use ((CHMP)) has issued a positive opinion recommending approval of Bylvay (odevixibat) for the treatment of Progressive familial intrahepatic cholestasis ((PFIC)).PFIC is a rare and devastating disorder affecting young children that causes progressive, life-threatening liver disease.The positive opinion for was supported by data from PEDFIC 1 and PEDFIC 2 Phase 3 trials, wherein Bylvay met both its pruritus (p=0.004) and serum bile acid (p=0.003) primary endpoints and was well tolerated.With this positive CHMP opinion, Bylvay continues on the accelerated approval path for European Commission ((EC)) decision on the marketing authorization application and an anticipated launch in H2.In addition, the Company also anticipates a regulatory decision in U.S. for the treatment of pruritus in patients with PFIC. The FDA has granted Priority Review and set a PDUFA goal date of July 20, 2021.ALBO shares up 2.7% premarket trading at $32.30.

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Albireo receives positive CHMP opinion for Bylvay for rare liver disease