ALK has received marketing authorisation from the European Commission for EURneffy 1 mg, the first and only needle-free adrenaline treatment for anaphylaxis in children aged four years and above across the European Union.

The nasal spray is indicated for emergency treatment of severe allergic reactions caused by insect stings, foods, medications and other allergens, as well as idiopathic and exercise-induced anaphylaxis in children weighing between 15 kg and 30 kg. The approval expands on the earlier authorisation of EURneffy 2 mg, approved in 2024 for adults and children weighing 30 kg or more.

Anaphylaxis, the most severe and life-threatening form of allergic reaction, requires immediate treatment and affects a significant number of children across Europe each year. Food allergies account for a majority of these cases, highlighting the need for accessible and easy-to-use emergency therapies.

EURneffy delivers adrenaline through a nasal spray, offering a portable, needle-free alternative to traditional auto-injectors. The device is designed to improve ease of use, particularly in emergency situations where hesitation or improper administration of injections can delay treatment. Clinical data from studies involving over 700 participants indicate rapid absorption of adrenaline and a safety profile comparable across paediatric and adult populations.

Experts note that traditional adrenaline auto-injectors, while effective, are often underutilised due to fear of needles and incorrect usage. The availability of a needle-free option is expected to improve adherence and timely administration during emergencies.

The approval applies across all 27 EU member states, as well as Iceland, Norway and Liechtenstein. EURneffy is also approved under the brand name neffy in markets including the United States, Japan and China.

The development marks a significant step forward in allergy care, offering a user-friendly and accessible solution for managing life-threatening allergic reactions, particularly among children and caregivers.