MHRA approves needle-free adrenaline nasal spray for anaphylaxis

Anaphylaxis is a sudden, extreme and sometimes life-threatening allergic response that causes a drop in blood stress and respiration difficulties. Picture credit score: Dave Hoeek through Shutterstock.com.

The UK Medicines and Healthcare merchandise Regulatory Company (MHRA) has granted approval for EURneffy, an adrenaline (epinephrine) nasal spray for treating anaphylaxis.

Developed by US biotech ARS Prescription drugs and underneath unique license within the UK by Danish pharmaceutical firm ALK-Abelló, the single-dose nasal spray is indicated to be used in adults and kids weighing over 30kg and delivers its complete contents (2mg) upon activation.

Anaphylaxis is an allergic response characterised by respiration difficulties and a drop in blood stress. The response will be life-threatening in some people.

MHRA interim government director of healthcare high quality and entry Julian Seaside commented: “Affected person security is our high precedence, which is why we’re happy to approve the primary needle-free nasal spray formulation of adrenaline for the emergency remedy of anaphylaxis within the UK. Till now, adrenaline for self-administration has solely been accessible through auto-injectors.

“Whereas this represents an essential new choice, adrenaline auto-injectors stay an important and doubtlessly life-saving remedy, giving individuals experiencing anaphylaxis invaluable time earlier than emergency assist arrives.”

ALK signed an settlement with ARS for the unique licensing and commercialisation rights to EURneffy within the UK and EU final 12 months. The spray’s UK approval follows its launch in Spain in 2024 and in Germany final month.

ALK additionally holds the rights for EURneffy in Canada whereas ARS has established licensing partnerships for the spray in China, Japan, and Australia and New Zealand with Pediatrix Therapeutics, Alfresa Pharma, and CSL Seqirus, respectively.

In Could, ALK entered a four-year co-promotion settlement with ARS for its nasal spray within the US – by which the spray is marketed as neffy – to co-promote it to as much as 9,000 paediatricians. Beneath the settlement, ALK can be eligible for a performance-related income share offered that internet gross sales exceed sure market share thresholds from the focused paediatrician prescribers, as per a information launch from the corporate.

A number of progressive epinephrine supply strategies are in growth for anaphylaxis as options to injections. These embrace Anaphylm, a fast-dissolving sublingual strip developed by US firm Aquestive Therapeutics.

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