EURneffy® 1 mg (adrenaline nasal spray) Recommended for Approval in the EU for Emergency Treatment of Type 1 Allergic Reactions, including Anaphylaxis in Children Weighing ≥15 kg to <30 kg

Core Viewpoint - ARS Pharmaceuticals has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization of EURneffy 1 mg, a needle-free adrenaline nasal spray for emergency treatment of anaphylaxis in children weighing between 15 kg and 30 kg in the European Union [1][2][3] Group 1: Product Information - EURneffy 1 mg will be the first and only needle-free adrenaline option available for younger children in the EU, addressing significant barriers to timely treatment [1][3] - The product is designed for emergency treatment of allergic reactions, including anaphylaxis due to insect stings, foods, and other allergens [1][5] - The 1 mg dose follows the previously approved EURneffy 2 mg for adults and children weighing 30 kg or more, which was authorized in August 2024 [2] Group 2: Market and Distribution - ALK-Abelló A/S, the partner of ARS Pharma, will distribute EURneffy in the EU following the expected authorization by the European Commission [1] - The marketing authorization will be valid across all EU member states, as well as Iceland, Liechtenstein, and Norway [2] Group 3: Company Background - ARS Pharmaceuticals is focused on empowering at-risk patients and their caregivers to protect against allergic reactions that could lead to anaphylaxis [15] - The company is also commercializing neffy in the U.S. for emergency treatment of allergic reactions in adults and children weighing at least 33 pounds [4][5] - Recent regulatory approvals for neffy have occurred in Japan, China, and Australia, indicating a global expansion strategy [4]