According to ARS Pharmaceuticals, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the company’s marketing application for EURneffy adrenaline nasal spray for the emergency treatment of anaphylaxis in patients who weigh more than 30 kg. ARS announced the submission of the application in January 2025 and announced that CHMP has issued a positive opinion regarding the application at the end of June. ALK-Abelló acquired the rights to market the nasal spray in the UK, as well as in other countries, in November 2024.
EURneffy has been approved in Europe since August 2024. In the US, the FDA approved the nasal spray (as neffy epinephrine nasal spray) for the treatment of anaphylaxis in patients who weigh 30 kg or more in August 2024. ARS later submitted an sNDA for a lower dose of neffy for the treatment of anaphylaxis in children weighing 15 to 30 kg (33-66 lbs), and that application was approved in March 2025.
ARS Pharma President and CEO Richard Lowenthal commented, “The approval of EURneffy marks a major milestone as the first needle-free adrenaline treatment available in the UK for adults and children with severe allergies. This innovation addresses a critical need for the many patients who may not carry, or hesitate to use, an injectable option in an emergency. The innovative design of EURneffy with its small size, temperature stability up to 50°C and longer shelf life compared to auto-injectors, encourages patients and caregivers to always carry and use epinephrine at the first sign of symptoms related to a food or venom allergy reaction. We are pleased to receive this approval and expand availability of our epinephrine nasal spray as part of our partnership with ALK-Abelló A/S.”
Read the ARS Pharmaceuticals press release
