Europe Nears Approval of Needle-Free Adrenaline Spray for Young Children

A new nasal adrenaline spray for young children at risk of severe allergic reactions has moved closer to approval in Europe. The European Medicines Agency's (EMA) expert committee has backed EURneffy 1 mg, a needle-free device designed for children weighing between 15 kg and 30 kg. This follows the earlier launch of a higher-dose version for older patients in 2025.

The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on EURneffy 1 mg, extending the existing approval for EURneffy 2 mg. That stronger dose, intended for adults and children over 30 kg, reached selected European markets and the UK in 2025 under ALK's distribution. Once formally authorised, the 1 mg spray will be available across all EU member states, plus Iceland, Liechtenstein, and Norway.

The 1 mg dose targets a critical gap in emergency care, as around 25% of epinephrine auto-injector use in Europe involves younger children. Unlike traditional injectors, neffy (known as EURneffy in the EU) delivers adrenaline through a nasal spray. It requires no needle, is compact, and resists temperature extremes, including accidental freezing.

Users should administer the spray immediately at the first sign of an allergic reaction. If symptoms persist or worsen, a second dose—using a new device in the same nostril—is recommended. Health authorities advise carrying two sprays at all times, as anaphylaxis can recur unexpectedly.

The product is already on sale in the US and has secured approvals in multiple countries. Further regulatory green lights are anticipated in the near future.

The CHMP's decision paves the way for EURneffy 1 mg to enter European pharmacies, offering a simpler alternative to injectable adrenaline for young children. With its robust design and ease of use, the nasal spray aims to improve response times during life-threatening allergic emergencies.