ARS Pharmaceuticals has received the UK Medicines and Healthcare products Regulatory Agency (MHRA) approval for its adrenaline nasal spray, EURneffy.
EURneffy is a nasal spray used for the emergency treatment of allergic reactions, including anaphylaxis, in adults and children aged four years and older who weigh 33lbs or greater.
It is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in both adult and paediatric patients within this weight and age range.
EURneffy is the first needle-free emergency treatment approved for allergic reactions, including anaphylaxis, in adults and children over 30kg.
In November 2024, ARS Pharma signed a licensing agreement with ALK-Abelló, granting the rights to commercialise neffy in the markets outside the US.
The pharmaceutical company retained commercial rights in the US, maintaining existing partnerships in Australia, China, Japan, and New Zealand.
It has received a $145m upfront payment in 2024 and is eligible for up to an additional $320m in regulatory and commercial milestone payments.
Also, it will receive tiered double-digit royalties on net sales in the licensed territories.
ARS Pharma co-founder, president and CEO Richard Lowenthal said: “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.
“The innovation addresses a critical need for the many patients who may not carry, or hesitate to use, an injectable option in an emergency.
“The innovative design of EURneffy with its small size, temperature stability up to 50°C and longer shelf life compared to auto-injectors, encourages patients and caregivers to always carry and use epinephrine at the first sign of symptoms related to a food or venom allergy reaction.”
EURneffy is already available in the US, under the brand name neffy, for treating allergic reactions, including anaphylaxis, in adults and children aged four years and at least 15kg.
In May this year, ARS and ALK initiated a four-year co-promotion agreement to reach around 20,000 healthcare providers, focusing on paediatricians during the back-to-school season.
In June, ALK launched EURneffy in Germany, with regulatory approvals underway in Canada, Japan, and Australia, and commercial rollouts planned for early 2026.
ARS Pharma anticipates the regulatory approval in China in 2026, expanding the availability of its needle-free treatment worldwide.
