ARS Pharmaceuticals announced that the European Commission has approved the company’s EURneffy adrenaline nasal spray for the treatment of anaphylaxis. The approval comes soon after the FDA’s approval of the US version, Neffy epinephrine nasal spray. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the EURneffy MAA in June 2024.
According to ARS Pharma, the company expects that EURneffy will be launched in Europe by the end of the year “by a pharmaceutical company with an already established commercial footprint in Europe.” Recordati previously held the European marketing rights to the epinephrine nasal spray but returned those rights to ARS in February 2023.
ARS Pharma President and CEO Richard Lowenthal commented, “Today’s approval marks an important moment for the severe allergy community in the EU, and the first novel adrenaline delivery method in more than three decades. 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.”
Read the ARS Pharmaceuticals press release.
