EURneffy adrenaline nasal spray approved for use in the EU
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Key takeaways:
- EURneffy should be available in the EU by October 2024.
- It is the first needle-free anaphylaxis treatment option in the EU.
The European Commission has approved EURneffy for the emergency treatment of allergic reactions, according to a press release by ARS Pharmaceuticals, producer of the drug.
This announcement follows the U.S. FDA approval of neffy earlier this month. EURneffy is the trade name for neffy in the European Union. The adrenaline nasal spray, approved for adults and children weighing at least 30 kg, is the first needle-free treatment option in the EU.
“Adrenaline is the only first-line treatment for allergic reactions including anaphylaxis, yet there is significant underutilization of adrenaline due to the limitations of current available therapy,” 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 treatment guidelines for anaphylaxis, said in the press release.
The co-founder, president and CEO of ARS pharmaceuticals, Richard Lowenthal, MS, MSEL, noted that the approval marked an important moment for the severe allergy community in the EU and called it the first novel delivery method for epinephrine in more than 30 years.
“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, which improves the outcome of allergic reactions,” he said in the release.
The approval of EURneffy follows the review of data from what the release calls extensive nasal spray development programs that involved over 700 study participants and 1,200 administrations, in addition to studies and peer-reviewed literature substituting or supporting tests and studies.
EURneffy is anticipated to become available in certain EU member states by the fourth quarter of this year.