Today, an expert committee of the European Medicines Agency (EMA) announced it had recommended approval of ARS Pharmaceuticals‘ nasal epinephrine treatment for severe allergic reactions. The agency generally follows recommendations from such committees.
EURneffy, the trade name for the drug in Europe, is a needle-free alternative to epinephrine auto-injectors. Rather than requiring a jab to the outer thigh to activate, the device sprays a fine mist into a nostril when administered, where it is quickly absorbed and delivered throughout the body.
The nasal spray — trademarked neffy® in the US — is currently being reviewed by the US Food and Drug Administration (FDA), which is expected to approve the drug on or before October 2. Despite all indications to the contrary, the FDA disregarded the advice of its expert committee last year and requested additional studies, which have been completed and submitted by ARS.
Said Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharmaceuticals:
Today’s announcement marks a major milestone in the treatment of severe allergies and moves us one step closer to bringing EURneffy to patients in the EU as the first and only needle-free adrenaline option for the emergency treatment of allergic reactions, up to anaphylaxis. EURneffy’s needle-free, smaller form and longer and less temperature-sensitive shelf-life may increase the likelihood that patients will both carry and administer adrenaline [epinephrine], which improves outcome of allergic reactions.
Approval of EURneffy in the EU is expected in the third quarter of this year.
