Ipsen Receives Approval for Bylvay in Japan to Treat Pruritus Linked to PFIC

Written by Emily J. Thompson, Senior Investment Analyst

Updated: Sep 19 2025

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Regulatory Approval: Japan's Ministry of Health, Labour and Welfare has approved Bylvay for treating pruritus associated with progressive familial intrahepatic cholestasis (PFIC), a rare genetic disorder causing bile acid accumulation in the liver.
Clinical Study Results: The approval was based on a Phase III study in Japan that demonstrated the efficacy and safety of odevixibat in pediatric patients, showing improvements in serum bile acid levels and pruritus, aligning with global study results.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.