Needle-free adrenaline treatment approved for young children in UK first

The first and only needle-free adrenaline treatment for children aged four years and older experiencing anaphylaxis has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).

The UK’s medicines watchdog made the announcement on Friday (12 June) after it granted marketing authorisation for EURneffy 1mg, for children aged four and older living with severe allergies in the UK.

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Flora Beiche-Scholz, executive vice president of commercial operations in 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.’

The drug’s manufacturer, ALK-Abelló, noted that EURneffy 1mg is now indicated for the emergency treatment of severe allergic reactions caused by insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis in children aged 4 years and over weighing between 15 kg and 30 kg.

This approval follows the existing UK marketing authorisation for EURneffy 2 mg, previously approved by the MHRA for the emergency treatment of anaphylaxis in adults and children 10 years and older weighing 30 kg or more.

The manufacturer highlighted that the nasal spray delivers a dose into the nostril and is suitable for use even if the nose is congested.

A spokesperson for ALK-Abelló, UK and Republic of Ireland said: ‘The adrenaline in EURneffy® is absorbed through the nasal mucosa using a proprietary absorption enhancer, Intravail (dodecyl maltoside).

‘Intravail temporarily loosens tight junctions in the nasal mucosa, allowing adrenaline to enter the bloodstream rapidly and efficiently.

‘This means that patients do not need to inhale for the medicine to take effect, making it a suitable adrenaline option even when individuals experience respiratory distress.’

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The MHRA noted that, as with adrenaline auto-injectors, two doses of the nasal spray must always be carried in case a second dose is needed before the ambulance arrives. Furthermore, ‘999’ must be dialled immediately after a dose has been given.

EURneffy 2mg has a total shelf life of 30 months and EURneffy 1mg has a total shelf life of 24 months. There are no special storage requirements and freezing does not affect the product’s shelf life.

Upon activation, EURneffy nasal spray delivers a full, single dose of adrenaline, without the need for priming.

Anaphylaxis – the most severe, life‑threatening form of allergic reaction requiring immediate intervention – affects an estimated 1 to 761 out of every 100,000 children in Europe each year, with food allergies responsible for more than two‑thirds of cases.

While anaphylaxis is not uncommon, death from anaphylaxis is very rare. According to the charity, Beat Anaphylaxis, around 20 deaths from it reported each year in the UK.

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