EMA Authorised: Ogsiveo (nirogacestat hydrobromide) — SpringWorks Therapeutics Ireland Limited

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Summary

EMA authorised Ogsiveo (nirogacestat hydrobromide) for desmoid tumors, designated as an orphan medicine in the EU.

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Diseases / indications

• Desmoid-type Fibromatosis

Drugs mentioned

• OGSIVEO (NIROGACESTAT)

Snippet

Status: Authorised. Therapeutic area: Desmoid Tumors. MAH: SpringWorks Therapeutics Ireland Limited. Decision date: 23/09/2025. Orphan medicine