According to ALK, the EMA’s Committee for Medicinal Products for Human Use has recommended approval of a 1 mg dose of EURneffy adrenaline nasal spray for the treatment of anaphylaxis in children who weigh between 15 kg and 30 kg. EURneffy has been approved in Europe for the treatment of anaphylaxis in people weighing at least 30 kg since August 2024. ALK-Abelló acquired the rights to market the nasal spray in much of the world from ARS Pharmaceuticals in November 2024.
In the US, where the product is marketed as neffy epinephrine nasal spray, the FDA approved the use of a 2 mg dose of neffy in patients who weigh 30 kg or more in August 2024; ARS submitted an sNDA for the lower dose of neffy for use in children weighing 15 to 30 kg in the following month, and that application was approved in March 2025. The Chinese National Medical Products Administration recently approved the 2 mg dose of neffy for patients who weigh 30 kg or more. The Japanese PMDA approved both the 1 and 2 mg doses in September 2025.
ALK Executive VP of R&D Henriette Mersebach commented, “We are delighted with the European health authorities’ recommendation to grant the EURneffy 1 mg marketing authorization which, if approved, will reinforce our pediatric focus by complementing the tablet approvals already obtained for treatment of children with respiratory allergy. EURneffy 1 mg has the potential to transform the lives of those living with or caring for children with severe allergic reactions, offering a needle-free, ready-to-use adrenaline solution.”
Read the ALK press release
