EMA Authorised: Lyvdelzi (previously Seladelpar Gilead) (seladelpar lysine dihydrate) — Gilead Sciences Ireland Unlimited Company

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Summary

The EMA authorised Lyvdelzi (seladelpar lysine dihydrate) for liver cirrhosis with biliary involvement. The approval is conditional and designated as an orphan …

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Diseases / indications

• Liver Cirrhosis

Drugs mentioned

• Lyvdelzi (seladelpar lysine dihydrate)

Snippet

Status: Authorised. Therapeutic area: Liver Cirrhosis, Biliary. MAH: Gilead Sciences Ireland Unlimited Company. Decision date: 05/12/2025. Conditional approval. Orphan medicine