ARS Pharmaceuticals announces CHMP of EMA adopted positive opinion for EURneffy

ARS Pharmaceuticals (SPRY) 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 authorization for EURneffy to include a 1 mg nasal adrenaline spray. EURneffy 1 mg is for the emergency treatment of allergic reactions due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis, in children who weigh greater than or equal to15 kg and less than 30 kg. The opinion supports an extension to EURneffy 2 mg approval granted by the European Commission in August 2024 for the emergency treatment of anaphylaxis in adults and children who weigh greater than or equal to3 0 kg. Following grant of 1 mg dose, the marketing authorization will be valid in all EU member states, as well as Iceland, Liechtenstein and Norway.