Danish pharmaceutical company ALK-Abelló A/S (ALK) (CPH:ALK-B) announced on Tuesday that the European Commission has granted marketing authorisation for EURneffy 1 mg, enabling a needle-free adrenaline treatment for anaphylaxis in children aged 4 years and older weighing between 15 kg and 30 kg.

This approval extends the company's existing EURneffy 2 mg authorisation, which was previously approved for adults and children weighing 30 kg or more.

EURneffy 1 mg is indicated for the emergency treatment of anaphylaxis triggered by allergens including insect stings, foods, and medicinal products, as well as idiopathic or exercise-induced cases. The approval applies across all EU member states, as well as Iceland, Norway, and Liechtenstein.

Clinical data supporting the decision demonstrated rapid adrenaline absorption within minutes and a consistent safety profile across a development programme involving over 700 participants. The most common adverse reactions in paediatric patients included nasal and upper respiratory tract congestion, dry throat, nasal dryness, and paraesthesia, with no clinically relevant safety differences versus adult populations.

EURneffy offers a portable nasal spray alternative to injectable adrenaline, with comparable pharmacodynamic effects and dosing performance across age and weight groups, supporting broader access to emergency treatment for severe allergic reactions.