Ipsen’s Bylvay wins PFIC approval in Japan

Mid-size French drugmaker Ipsen (Euronext: IPN) has announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted regulatory approval for Bylvay (odevixibat) for the treatment of pruritus associated with progressive familial intrahepatic cholestasis (PFIC). 

PFIC is a group of rare genetic disorders in which bile acid accumulates in the liver, leading to progressive liver damage and potentially liver failure. 

The condition severely impacts quality of life through debilitating symptoms such as severe itching (pruritus), caused by the bile accumulation in the liver and bloodstream, which can cause skin mutilation, sleep disruption, irritability, and impaired cognitive and social development.