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EMA approval · 2025-08-13

EMA Authorised: Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) (chenodeoxycholic acid) — Leadiant GmbH

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Summary

The EMA authorised Chenodeoxycholic acid Leadiant for Cerebrotedinous xanthomatosis (a rare inborn error of metabolism) with orphan designation.

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Diseases / indications

Drugs mentioned

  • Chenodeoxycholic acid Leadiant (chenodeoxycholic acid)

Snippet

Status: Authorised. Therapeutic area: Xanthomatosis, Cerebrotendinous;Metabolism, Inborn Errors. MAH: Leadiant GmbH. Decision date: 23/07/2025. Orphan medicine