ALBO - Albireo's odevixibat nabs accelerated review in U.S. for liver disease

Under priority review, the FDA accepts Albireo Pharma's (ALBO) New Drug Application ((NDA)) for odevixibat for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis ((PFIC)).The FDA has set PDUFA goal date of July 20, 2021, supporting company's previous guidance of a planned launch in H2 2021.Odevixibat previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. PFIC is a rare and devastating disorder that causes progressive, life-threatening liver disease.Also, Albireo will host a virtual Commercial Day for investors on February 11 and provide an overview of the long-term corporate strategy.Shares up 4% premarket.

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Albireo's odevixibat nabs accelerated review in U.S. for liver disease