Younger children in the UK will now have a needle-free option to treat serious allergic reactions after the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved a new dose of ALK-Abelló’s EURneffy.
The new lower dose version of EURneffy – an adrenaline nasal spray – means children aged 4 years and over who weigh between 15kg and 30kg are now eligible to take the drug. This expansion to a 1mg dose extends beyond the previously authorised 2mg product, which was approved for adults and children 10 years and above weighing 30kg or more in July 2025.
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Anaphylaxis, a severe allergic reaction, typically occurs when the body’s immune system develops an immediate and unexpected response to a foreign substance, which can come from food, insect stings, or medications. Anaphylaxis affects up to an estimated 761 out of every 100,000 children in Europe each year, with food allergies responsible for more than two‑thirds of cases.
Adrenaline is a well-established treatment for serious allergic reactions and is intended for immediate self-administration at the first signs of anaphylaxis.
Injectable products, like Mylan’s EpiPen (adrenaline injection), are currently the go-to treatment for patients undergoing an anaphylactic reaction. Despite their efficacy, ALK has highlighted limitations in auto-injectors, such as delayed treatment in needle-adverse patients. Analysts comment that the nasal spray offers a simpler and more user-friendly option compared to EpiPen, the latter having had its fair share of pricing controversies over the past decade.
Flora Beiche-Scholz, ALK’s executive vice president for commercial operations Europe, said: “For decades, children at risk of anaphylaxis have been limited to injectable adrenaline – yet fear of needles, hesitancy to act and incorrect administration mean adrenaline is too often not carried or used in time. EURneffy 1mg aims to address these barriers, offering a needle-free adrenaline solution with the potential to transform the lives of those living with, or caring for, children with severe allergies.”
ALK gained European and Canadian rights to EURneffy from developer ARS Pharmaceuticals in a $145m upfront deal in November 2025. ARS maintained US marketing rights, where the spray is known under the brand name Neffy. In March 2026, the US Food and Drug Administration (FDA) also widened the paediatric label for the spray.
As per ARS, Neffy generated $20.3m in full-year 2025 sales. According to GlobalData, the drug will reach $1bn in global net sales in 2032.
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