ALK wins UK approval for needle-free anaphylaxis spray

Danish drugmaker ALK-Abelló said Friday it has won regulatory approval in the U.K. for its needle-free adrenaline nasal spray used to treat severe allergic reactions.

The approval from the Medicines and Healthcare Products Regulatory Agency makes EURneffy the first adrenaline nasal spray available for treating anaphylaxis in the country, which the company described as Europe’s largest market for such treatments.

The 2 mg spray is approved for adults and children weighing 30 kilograms or more, with a market launch expected in the coming months following market access negotiations, ALK said.

The spray, developed by U.S.-based ARS Pharmaceuticals, is designed as an easier-to-use alternative to adrenaline auto-injectors and has a longer shelf life, according to the company.

“The approval of EURneffy® 2 mg in the UK introduces an alternative and novel adrenaline treatment option for adult and adolescent patients with life-threatening allergies,” said Henriette Mersebach, ALK’s Executive Vice President of R&D.

“EURneffy® could improve the lives of people with severe allergic reactions and may facilitate that patients and caregivers continually carry adrenaline wherever they go.”

The company said the approval was based on data from over 700 participants, which showed the spray’s effects were comparable to auto-injectors, with no serious adverse events reported in clinical studies.

The approval follows the product's first European market launch in Germany last month.

The announcement does not affect ALK’s financial guidance for 2025, the company said.