EMA Recommends Approval of Needle-Free Adrenaline Spray for Younger Children in EU

Event summary

  • EMA's CHMP recommends expanding EURneffy® 1 mg approval for children weighing 15 kg to <30 kg.
  • ARS Pharma's partner ALK-Abelló A/S will distribute the product post-European Commission authorization.
  • EURneffy 1 mg is the first needle-free adrenaline option for younger children in the EU.
  • Approval follows the 2024 authorization of EURneffy 2 mg for adults and children ≥30 kg.
  • neffy is already commercially available in the U.S. and launched in select EU countries in 2025.

The big picture

This recommendation addresses a significant gap in emergency treatment options for younger children, who represent about 25% of epinephrine auto-injector use in Europe. The needle-free design of EURneffy could drive broader adoption, particularly among caregivers hesitant to use traditional injectable devices. ARS Pharma's expansion into pediatric markets aligns with global trends toward more accessible and user-friendly emergency treatments.

What we're watching

Regulatory Execution
Whether the European Commission will finalize approval and the timeline for market availability.
Market Penetration
The pace at which EURneffy 1 mg gains adoption among parents and caregivers of younger children.
Competitive Dynamics
How this approval affects the positioning of traditional epinephrine auto-injectors in the EU market.