Shots:
Inconsistent access to epinephrine auto-injectors continues to be a major unmet need in the management of anaphylaxis
neffy, an innovative intranasal epinephrine spray, provides a needle-free alternative for the emergency treatment of severe allergic reactions, including anaphylaxis, in adults and children aged four years and older who weigh at least 33 lbs
Richard Lowenthal,…
Shots:
The UK’s MHRA has approved EURneffy 2mg (adrenaline nasal spray) to treat allergic reactions (anaphylaxis) in children (>30kg); commercially available in the UK by late Q3’25
In Nov 2024, ARS Pharma granted ALK exclusive rights to commercialize neffy outside the US, incl. EU (as EURneffy), Canada, & select markets in exchange for $145M upfront, ~$320M…
Shots:
The US FDA has approved neffy 1mg (epinephrine nasal spray) to treat type I allergic reactions (incl. anaphylaxis) in children [≥4yrs. & 15-30kg (33-66lbs)]; commercially available in the US by end of May’25
Approval was based on extensive clinical data with PK/PD results comparable to approved epinephrine injections in both pediatric & adult…
Shots:
Following the US FDA approval, the EC has approved Eurneffy (2mg) for type I allergic reactions (anaphylaxis) in adults & children (≥30kg). It will be available in Q4’24 through undisclosed pharmaceutical partner
The approval was supported by the results from a study, involving ~1200 administrations among >700 subjects, along with studies and peer-reviewed literature…

