ARS Pharmaceuticals Gets Positive Opinion For Expanded Marketing Authorization For EURneffy By EMA's Committee For Medicinal Products For Human Use

ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, announced today 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 (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis, in children who weigh ≥15 kg and <30 kg.

The opinion supports an extension to EURneffy 2 mg approval granted by the European Commission (EC) in August 2024 for the emergency treatment of anaphylaxis in adults and children who weigh ≥30 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.