EMA Authorised: Wakix (pitolisant) — Bioprojet Pharma

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Summary

EMA authorised Wakix (pitolisant) for narcolepsy with Bioprojet Pharma as the marketing authorisation holder; it is designated an orphan medicine. Decision date…

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Diseases / indications

• Narcolepsy

Drugs mentioned

• WAKIX (pitolisant hydrochloride)

Snippet

Status: Authorised. Therapeutic area: Narcolepsy. MAH: Bioprojet Pharma. Decision date: 19/01/2026. Orphan medicine