Real-world evidence supports clinical effectiveness of the neffy® nasal adrenaline spray

ALK (ALKB:DC / OMX: ALK B) today announced that real-world evidence evaluating the clinical performance of the nasal adrenaline spray neffy^® in US patients experiencing anaphylaxis symptoms during oral food challenge and allergen immunotherapy has been accepted for scientific publication. The findings represent the first large-scale analysis of treatment outcomes with neffy^® during routine clinical practice and were accepted for publishing as a correspondence in the Annals of Allergy, Asthma and Immunology, the official journal of the American College of Allergy, Asthma and Immunology.

The analysis showed that 89.2% of 545 patients experiencing anaphylaxis symptoms during oral food challenge and allergen immunotherapy were successfully treated with a single dose of neffy^® by a healthcare provider, while 10.8% of the 545 patients required a second dose. These results suggest real-world effectiveness of neffy^® to be consistent with historic response rates observed with adrenaline injection that report a similar proportion of patients, 88.9%, being successfully treated with a single dose of adrenaline intramuscular injection or auto-injector by a healthcare provider for food-induced anaphylaxis, and 11.1% of patients requiring a second dose.

neffy^® is a ready to use, needle-free nasal adrenaline spray approved for timely emergency anaphylaxis treatment developed by US-based ARS Pharmaceuticals, Inc. Based on the license agreement entered in November 2024, ALK holds exclusive global rights to commercialise neffy^® (branded EURneffy^® in the EU and the UK) with exception of the USA, Australia, New Zealand, Japan, and China. In May 2025, the partnership was extended to include a co-promotion agreement in the USA. The EURneffy^® nasal adrenaline spray was launched in the first EU market, Germany, in the end of June 2025 and additional launches are planned before year-end.

The observational analysis was based on data collected from healthcare providers participating in the neffy^® experience program. Healthcare providers were given six doses of neffy^® for use to rescue patients experiencing anaphylaxis symptoms during oral food challenge or allergen immunotherapy. neffy^® US labelling states that a second dose should be administered if anaphylaxis symptoms continue or get worse starting 5 minutes after the first dose. As of the March 2025 data cut-off, 301 healthcare providers had responded to the survey instrument, and a total of 545 patients were reported having been treated with neffy^® 2 mg. 486 of these patients had been successfully treated with a single dose of neffy^® 2 mg, with the remaining 59 patients requiring a second dose of adrenaline. The neffy^® experience program is actively ongoing and now includes both the 2 mg and 1 mg doses.

ALK-Abelló A/S

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About ALK

ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at .

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