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Stock impact report

Bylvay® (odevixibat) approved in Japan for rare liver disease PFIC

IPSEN SA S/ADR (IPSEY) 
NASDAQ:AMEX Investor Relations: ipsen.com/investors
Company Research Source: GlobeNewswire
Bylvay® is the first once-daily ileal bile acid transport inhibitor to be approved as a treatment for pruritus associated with progressive familial intrahepatic cholestasis (PFIC) in Japan, offering a non-surgical treatment option for infants, young children and adults PFIC is a rare and life-threatening liver disease that affects an estimated 100 children and infants in Japan.1 Paris, France – 19 September 2025 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that Japan’s Ministry of Health, Labour 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 an Show less Read more
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