ALK announced that Health Canada has approved neffy 2 mg for the emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis in adult and paediatric patients (=30 kg). The approval addresses a critical need for Canadians affected by severe allergies that put them at risk of anaphylaxis. neffy constitutes the first approved nasal adrenaline spray for timely emergency treatment.

neffy is designed to fit into a pocket for portability. It also has a 30-month shelf life from time of manufacture and can withstand temperature excursions up to 50°C, key differentiators from adrenaline autoinjectors (AAIs). The regulatory approval was based on the review of data from the neffy development programme involving over 700 participants.

No serious side effects were reported in clinical studies with neffy. Moreover, the clinical development programme has generated important clinical evidence across a range of real-world clinical scenarios. It is estimated that up to 2,500,000 people in Canada are affected by severe allergies.

Canada will expectedly become ALK?s market outside of Europe. The market launch of neffy 2 mg in Canada is expected within the coming months. Submission for regulatory review in Canada of neffy 1 mg for children weighing 15-30 kg is expected later in 2026.

neffy is developed by US-based ARS Pharmaceuticals Inc. In November 2024, ALK entered into a strategic license agreement with ARS Pharma granting ALK exclusive global rights to commercialise neffy 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 approval does not affect ALK?s financial guidance for 2026.