MHRA green lights lower dose EURneffy nasal spray for children

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new lower dose version of ALK-Abelló’s EURneffy (epinephrine) 1mg nasal spray for anaphylaxis.

It provides the first needle-free adrenaline treatment for children four years old and over in the UK at risk of severe allergic reactions. Specifically, eligible patients weighing 5kg and 30kg.

Flora Beiche-Scholz, Exective Vice President, Commercial Operations Europe at ALK 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. This approval brings us closer to ensuring every family affected by severe allergies has a treatment they will actually carry and use.”

“EURneffy 1mg aims to address [current administration] 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”

Flora Beiche-Scholz, Exective Vice President, Commercial Operations Europe, ALK Pharmaceuticals

 

The MHRA initially approved a 2mg product of the needle-free allergy drug in July last year, for individuals 10 years old and above weighing 30 kg or more. As such, the agency’s latest decision extends a class of treatment previously available only by injection.

In developing EURneffy, “the first challenge was that there were no delivery methods approved other than injections, which were mostly approved without clinical studies”, nor was there an established regulatory path for non-needle delivery methods”, according to Dr Sarina Tanimoto, Chief Medical Officer of ARS Pharmaceuticals.

At the time, Richard Lowenthal, the company’s President and CEO remarked: “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.”