ARS Pharmaceuticals announced that the FDA has approved an sNDA to remove the age requirement for the 1 mg dose of neffy epinephrine nasal spray for the treatment of anaphylaxis. A 2 mg dose of neffy was approved by the FDA in August 2024 for the treatment of anaphylaxis in patients who weigh 66 lbs (30 kg) or more. ARS then submitted an sNDA for the 1 mg dose of neffy for use in children weighing 33 to 66 lbs (15 to 30 kg); the FDA approved the 1 mg dose for children in that weight range who were aged 4 or over in March 2025.
ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “We are very pleased that based on clinical data presented to FDA for neffy, that the agency removed the age requirement in the indication. This is a major advancement for the families with small children who live with the constant worry of severe allergic reactions in their youngest children.”
In Europe, where the product is marketed as EURneffy adrenaline nasal spray, ALK announced that the EC has approved a 1 mg dose for the treatment of anaphylaxis in children 4 and older who weigh at least 15 kg and up to 30 kg. ALK-Abelló acquired the rights to market the nasal spray in much of the world from ARS Pharmaceuticals in November 2024.
EURneffy was approved by the EMA for the treatment of anaphylaxis in people weighing at least 30 kg in August 2024. In January 2026, ALK announced that the the EMA’s Committee for Medicinal Products for Human Use had recommended approval of the 1 mg dose of EURneffy for children in the 15 -30 kg weight range.
ALK Executive VP of Commercial Operations Europe Flora Beiche-Scholz commented, “This approval reflects our continued commitment to expanding treatment options for children with severe allergies. For decades, children at risk of anaphylaxis have been limited to injectable adrenaline, yet fear of needles, hesitancy to act and incorrect administration mean adrenaline is too often not carried or used in time. EURneffy 1 mg aims to address these barriers, offering an efficacious, needle-free, user-friendly adrenaline solution with the potential to transform the lives of those living with, or caring for, children with severe allergies. This approval brings us closer to ensuring every family affected by severe allergies has a treatment they will actually carry and use.”
Read the ARS Pharmaceuticals press release
Read the ALK press release
