ALK Abello Secures EU Nod for Needle-Free Anaphylaxis Treatment for Young Children
Event summary
- ALK Abello's EURneffy® 1 mg received EU marketing authorization on March 31, 2026, for emergency treatment of anaphylaxis in children aged 4+ weighing 15–30 kg.
- This approval extends the existing authorization for EURneffy® 2 mg, granted in August 2024 for patients ≥30 kg.
- EURneffy® is the first and only needle-free adrenaline treatment approved in the EU, addressing barriers like needle fear and incorrect administration.
- Clinical trials involved over 700 participants, demonstrating rapid absorption and a comparable safety profile across pediatric and adult populations.
The big picture
ALK Abello’s approval for EURneffy® 1 mg addresses a critical gap in pediatric anaphylaxis treatment, offering a needle-free alternative in a market dominated by injectable solutions. The expansion into younger age groups could significantly broaden the product’s reach, particularly as food allergies drive a growing share of anaphylaxis cases in children. The strategic move positions ALK Abello to capture a larger share of the €1.2 billion global adrenaline auto-injector market, where innovation in delivery mechanisms is increasingly prioritized.
What we're watching
- Market Adoption
- How quickly EURneffy® 1 mg gains traction among parents and caregivers of young children with severe allergies.
- Regulatory Expansion
- Whether ALK Abello can secure approvals in additional markets beyond the EU, US, Japan, and China.
- Competitive Response
- The pace at which competitors develop or adapt needle-free adrenaline treatments to challenge EURneffy®'s market position.
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