The European Commission (EC) has approved EURneffy®, an adrenaline nasal spray, which is the first-and-only needle-free emergency treatment of allergic reactions (anaphylaxis).

The approval was granted following the review of data from one of the most extensive nasal spray development programs in history, involving more than 700 study participants and over 1,200 administrations, as well as studies and peer-reviewed literature, substituting or supporting tests and studies.

The pharmacodynamics and pharmacokinetics of 2mg EURneffy were evaluated across a range of dosing conditions, including single and repeat dosing, self-administration by patients, dosing in paediatrics, and during multiple nasal conditions that can cause congestion and rhinorrhea, such as nasal allergen challenge or infectious rhinitis caused by a cold or flu.

EURneffy benefits from an eight-year period of data protection, whereby another applicant cannot rely the data submitted as part of the EURneffy marketing authorisation application, and a ten-year period of marketing protection during which a generic, hybrid or biosimilar cannot be placed on the market in the EU.
The issued composition of matter and method of treatment patents covering EURneffy in Europe expire in 2039.

It is anticipated that EURneffy will be made available to patients in certain European Union Member States in Q4 2024 by a pharmaceutical company with an already established commercial footprint in Europe.

Antonella Muraro, MD PhD, Professor of Food Allergy at the University of Padua, and lead author of the European Academy of Allergology and Clinical Immunology (EAACI) treatment guidelines for anaphylaxis said: “Adrenaline is the only first-line treatment for allergic reactions including anaphylaxis, yet there is significant underutilisation of adrenaline due to the limitations of current available therapy. The approval of EURneffy provides the first needle-free treatment option available in the EU for adults and children (≥30 kg) with severe allergies, many of whom may not carry, or delay use of an injectable adrenaline product.”