EMA Authorised: Bylvay (odevixibat) — Ipsen Pharma

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Summary

EMA authorised Bylvay (odevixibat) from Ipsen Pharma for intrahepatic cholestasis as an orphan medicine with accelerated assessment.

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Diseases / indications

• Cholestasis
• Progressive Familial Intrahepatic Cholestasis

Drugs mentioned

• BYLVAY (odevixibat)

Snippet

Status: Authorised. Therapeutic area: Cholestasis, Intrahepatic. MAH: Ipsen Pharma. Decision date: 06/06/2025. Orphan medicine. Accelerated assessment