Dysport achieves positive topline Phase III results for both episodic and chronic migraine, positioning Ipsen for a potential new migraine preventive
Executive summary: Ipsen reported positive topline results from its Phase III BEOND trial of Dysport for episodic and chronic migraine prevention. Success could make Dysport the first botulinum toxin approved for both migraine types, expanding treatment options and potentially capturing share in the migraine preventive market.
Who is involved: Ipsen (Euronext: IPN; ADR: IPSEY) as sponsor, clinical investigators in the BEOND program, and participants with episodic and chronic migraine.
Likely next: Ipsen will likely submit a marketing authorization application to the EMA and FDA within the next 6–12 months to seek approval for Dysport in migraine prevention.
Ipsen announced that its Phase III BEOND program met primary endpoints in both episodic and chronic migraine studies evaluating Dysport (abobotulinumtoxinA). The positive topline data suggest Dysport could become the first botulinum toxin approved for migraine prevention in both populations. If approved, the product would add a new therapeutic option in a market dominated by oral CGRP antagonists and onabotulinumtoxinA (Botox) for chronic migraine only.
Timeline
- — Dysport est la première toxine botulinique à obtenir des résultats préliminaires positifs de phase III, à la fois dans la migraine épisodique et dans la migraine chronique. (GlobeNewswire)
Analysis — what this means
Sectors affected
- botulinum toxin migraine prevention
Key entities
Sources
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