ALK receives positive CHMP opinion for EURneffy 1mg (nasal adrenaline spray) for emergency anaphylaxis treatment in children (≥15kg)
January 30, 2026 – Biotechnology, Drug Discovery, Other, Pharmaceutical – ALK, CHMP, EMA, emergency anaphylaxis treatment, marketing authorisation
30 January 2026 — Hørsholm – Denmark — Today ALK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending expanding the marketing authorisation for EURneffy to include a 1mg nasal adrenaline
spray for the emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exerciseinduced anaphylaxis in children aged 4 years and older with a bodyweight between 15kg and 30kg.
The opinion supports an extension to the marketing authorisation for EURneffy 2mg granted by the European Commission (EC) in August 2024 for the emergency treatment if anaphylaxis in adults and children who weigh ≥30kg.
If approved, this extension will mean more people with severe allergies, including children aged 4 years and older, weighing between 15kg and 30kg, will be eligible for treatment with EURneffy, the first
and only needle-free adrenaline-based product across the European Union (EU).
Executive Vice President of R&D, Henriette Mersebach (MD) commented: “For decades, treatment options for children with life-threatening severe allergies have been limited to injectable adrenaline devices. We are delighted by today’s news that the CHMP have recommended an extension to the EURneffy marketing authorisation to include a 1mg dose for children aged 4 years and older with a bodyweight between 15kg
and 30kg. If approved, EURneffy 1mg has the potential to transform the lives of those living with or caring for children with severe allergies, offering a needle-free, ready-to-use adrenaline solution.”
Clinical Evidence and Safety Profile
- EURneffy provides rapid absorption of adrenaline within minutes of administration
- EURneffy has an established safety profile, based on clinical data from the EURneffy development programme involving over 700 participants
- The most common adverse reactions in subjects weighing 15kg to less than 30kg treated with EURneffy 1mg included: nasal congestion (19.0%), upper respiratory tract congestion (14.3%), dry throat, nasal dryness, and paraesthesia (each 9.5%)
- There were no clinically relevant differences in the safety between the paediatric and adult populations treated with EURneffy
- EURneffy 2mg performed as well as traditional adrenaline auto-injectors or intramuscular adrenaline across a range of real-world scenarios examining the clinical pharmacological effect including single and repeat doses, selfadministration, and situations with nasal congestion from allergies
- EURneffy 1mg dose demonstrated a comparable absorption and pharmacodynamic effect in children (15-30kg) as the 2mg dose in children and adults above 30kg.
Anaphylaxis is the most severe form of allergic reaction – it can be life-threatening and requires immediate medical intervention. In Europe, the anaphylaxis incidence rate is approximately 1 to 761 out of every 100,000 children each year, with a higher predominance in boys. Foods are now the most common trigger of anaphylaxis in children, accounting for more than two-thirds of cases, and hospitalisations as a result of
food allergies in children are increasing.
The positive opinion will now be reviewed by the EC. If granted, the marketing authorisation will be valid in all EU member states, as well as Iceland, Liechtenstein and Norway.
About ALK
ALK is a global specialty pharmaceutical company focused on allergy. ALK’s activities cover the
entire value chain of developing, sourcing, producing, and marketing a diversified portfolio of
products for diagnosing and treating respiratory allergies and severe allergic reactions
(anaphylaxis) in both children and adults. Headquartered in Denmark, ALK employs around 2,700
people worldwide and is listed on Nasdaq Copenhagen (Nasdaq: ALK B). Visit us at www.alk.net.
