ALK has announced that its EURneffy 1mg nasal adrenaline spray has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for emergency anaphylaxis treatment in children in children aged four years and older with a bodyweight between 15 and 30kg.
Anaphylaxis is the most serious type of allergic reaction, occurring in one to 761 in every 100,000 children each year in Europe. It is more common in boys. Food allergies account for over two thirds of anaphylaxis cases, with food allergy-related hospitalisations on the rise.
The CHMP’s positive opinion of EURneffy encompasses anaphylaxis caused by insect stings and bites, foods, medications and other common allergens. It also includes idiopathic and
exercise-induced anaphylaxis.
The European Commission (EC) previously granted marketing authorisation in September 2024 to EURneffy 2mg, for the treatment of anaphylaxis in adults and children weighing more than 30kg. EURneffy is the first and only needle-free adrenaline-based product to receive authorisation in the EU.
EURneffy has been found to be rapidly absorbed, and to perform as well as traditional injectable forms of anaphylaxis treatment. It also has a favourable tolerability and safety profile.
The positive opinion expressed by the CHMP will be reviewed by the EC with a view to authorisation of EURneffy 1mg. The authorisation, if granted, would apply to all EU member states and Iceland, Liechtenstein and Norway.
“For decades, treatment options for children with life-threatening severe allergies have been limited to injectable adrenaline devices,” Henriette Mersebach, executive vice president of R&D at ALK, said. “If approved, EURneffy 1 mg 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.”
