ALK Secures EU Nod for Pediatric Anaphylaxis Treatment, Expanding Market Reach
Event summary
- CHMP recommends marketing approval for EURneffy® 1 mg, a needle-free anaphylaxis treatment for children aged 4+ weighing 15–30 kg.
- Approval extends ALK’s existing EURneffy® 2 mg authorization, granted in August 2024, to a broader pediatric population.
- ALK licensed exclusive global rights (excluding key markets) to neffy® from ARS Pharmaceuticals in November 2024, with a U.S. co-promotion deal added in May 2025.
- European Commission review pending; final approval expected within months, valid across EU, Iceland, Liechtenstein, and Norway.
The big picture
ALK’s expanded approval for EURneffy® 1 mg reinforces its position in pediatric allergy care, complementing its tablet-based respiratory allergy treatments. The move aligns with broader industry trends toward needle-free adrenaline delivery, addressing unmet needs in severe allergic reactions. With exclusive rights to neffy® outside key markets, ALK strengthens its competitive edge in Europe while leveraging its strategic partnership with ARS Pharmaceuticals for future growth.
What we're watching
- Regulatory Timing
- Whether the European Commission will approve the expanded indication as swiftly as anticipated, given the CHMP’s positive opinion.
- Commercial Execution
- How ALK will integrate and promote the pediatric formulation alongside its existing respiratory allergy portfolio.
- Market Penetration
- The pace at which EURneffy® 1 mg gains adoption in EU pediatric allergy care, particularly amid rising food allergy hospitalizations.
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