EURneffy® approved as UK's first needle-free anaphylaxis treatment for adults and children

ALK has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for their adrenaline nasal spray, EURneffy® 2 mg, in the United Kingdom. This innovative product is designed to treat anaphylaxis in adults and children weighing 30 kg or more and is expected to be launched in the UK market shortly after the finalization of market access negotiations.

EURneffy® is notable for being the first nasal spray of its kind approved in the UK for the quick treatment of severe allergic reactions like anaphylaxis. With the UK being the largest market for anaphylaxis in Europe, this approval is a significant milestone for ALK. The nasal spray offers a needle-free alternative to traditional adrenaline auto-injectors, featuring a user-friendly design that encourages more people to administer adrenaline swiftly and confidently during emergencies. This could lead to better emergency response outcomes and potentially save lives.

EURneffy® also boasts a longer shelf life of 30 months and enhanced temperature stability when compared to existing adrenaline auto-injectors. Henriette Mersebach, ALK’s Executive Vice President of Research and Development, emphasized the significance of this approval, highlighting that EURneffy® introduces a novel treatment option for individuals with life-threatening allergies. She noted that this nasal spray could significantly improve the quality of life for patients and caregivers by making it more feasible for them to carry adrenaline at all times.

The MHRA's decision to approve EURneffy® was based on comprehensive data collected from over 700 participants in the EURneffy® development program. The clinical studies reported no serious adverse effects, and the pharmacological data for EURneffy® 2 mg was consistent with that of traditional adrenaline auto-injectors, covering various dosing conditions.

Anaphylaxis impacts up to eight out of every 100,000 individuals annually in Europe, with one in 300 people experiencing it at some point in their lifetime. In such emergency situations, individuals often hesitate or experience uncertainty with larger auto-injectors. EURneffy® aims to address these issues by providing a more accessible and user-friendly option.

The development of neffy®, known as EURneffy® in the EU and UK, is the work of ARS Pharmaceuticals, Inc., a company based in the United States. ALK and ARS Pharmaceuticals entered a strategic license agreement in November 2024, granting ALK exclusive rights to market neffy® globally, except in the USA, Australia, New Zealand, Japan, and China. This partnership was further expanded in May 2025 to include a co-promotion agreement within the USA.

ALK is a globally recognized pharmaceutical company specializing in allergy and allergic asthma treatments. With a focus on allergy immunotherapy and a variety of other allergy-related products and services, ALK is headquartered in Hørsholm, Denmark, and employs approximately 2,800 individuals worldwide. The company is publicly listed on Nasdaq Copenhagen, reflecting its prominence in the pharmaceutical industry.