The UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized EURneffy for the emergency treatment of anaphylaxis in adults and children.
RT’s Three Key Takeaways:
- Needle-Free Administration: EURneffy provides the first non-injectable adrenaline option in the UK for adults and children weighing more than 30 kg.
- Device Durability: The nasal spray is temperature stable up to 50°C and has a longer shelf life than traditional adrenaline auto-injectors.
- Commercial Timeline: Distribution in the UK is expected to begin in late Q3 2025 through a partnership with ALK-Abelló A/S.
The United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for EURneffy (adrenaline nasal spray) for the emergency treatment of allergic reactions (anaphylaxis) in adults and children weighing more than 30 kg, according to ARS Pharmaceuticals.
The approval makes EURneffy the first needle-free adrenaline treatment available in the UK. ALK-Abelló A/S, which holds the rights to market the product in the UK, expects the treatment to be available in late Q3 2025, according to a news release.
“The approval of EURneffy marks a major milestone as the first needle-free adrenaline treatment available in the U.K. for adults and children with severe allergies. This innovation addresses a critical need for the many patients who may not carry, or hesitate to use, an injectable option in an emergency,” said Richard Lowenthal, co-founder, president and ceo of ARS Pharma, in a news release.
The UK represents the largest market for adrenaline auto-injector sales outside of the United States (US). According to ARS Pharmaceuticals, the design of the nasal spray includes temperature stability up to 50°C, a small size, and a longer shelf life compared to traditional auto-injectors to encourage consistent carrying by patients and caregivers.
In the US, the product is marketed as neffy and is approved for the emergency treatment of Type I allergic reactions in adults and children weighing at least 15 kg. The company also noted that regulatory decisions for the treatment in Canada, Japan, and Australia are expected by the end of 2025, with a China approval anticipated in 2026.
Common side effects associated with the treatment include nasal discomfort, headache, throat irritation, and nasal congestion, according to the company. Patients are advised to carry two nasal sprays at all times, as a second dose may be required if symptoms continue or return. The medication is intended for use at the first sign of symptoms related to a food, medication, or venom allergy reaction.
