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news.ALK has received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for EURneffy 1mg, a needle-free adrenaline treatment for children with anaphylaxis.
Anaphylaxis is a rapidly progressing and potentially life-threatening allergic reaction that requires immediate treatment. Credit: Evgeniia Primavera / Shutterstock.com.
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This approval is said to be the first in the UK for a needle-free adrenaline treatment for children aged four years and older, weighing between 15kg and less than 30kg, who are at risk of anaphylaxis.
It extends access to a treatment option previously confined to injection-based administration.
The newly authorised EURneffy 1mg can be used for emergency management of severe allergic reactions caused by insect stings, food, medicines, idiopathic or exercise-induced anaphylaxis in this paediatric group.
This follows the earlier MHRA approval of EURneffy 2mg for adults and children weighing 30kg or more in the UK.
Anaphylaxis is a rapidly progressing and potentially life-threatening allergic reaction that requires immediate treatment.
ALK Europe commercial operations EVP Flora Beiche-Scholz said: “This approval reflects our continued commitment to expanding treatment options for children with severe allergies. 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. This approval brings us closer to ensuring every family affected by severe allergies has a treatment they will actually carry and use.”
Clinical study data show EURneffy delivers adrenaline rapidly and demonstrates a comparable pharmacological response to traditional auto-injectors in both single and repeat doses.
The most commonly reported adverse reactions among children in the approved weight range were nasal congestion (19%), upper respiratory tract congestion (14.3%), and others such as dry throat, nasal dryness, and paraesthesia (each 9.5%).
No clinically relevant differences in safety were found between paediatric and adult populations.
EURneffy offers a portable, needle-free alternative to traditional adrenaline delivery, requires no special storage, and has a shelf life of 24 months for the 1mg dose.
