ARS Pharmaceuticals announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the company’s MAA for the European version of its Neffy epinephrine nasal spray. In April 2024, ARS announced that it had submitted a Day 180 response regarding the MAA for the nasal spray to CHMP. If approved, the European version will be marketed as EURneffy adrenaline nasal spray, the company said.
ARS noted that the EC decision on the MAA is anticipated in the 3rd quarter of this year and that it 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 acquired European marketing rights to the nasal spray in September 2020; however, those rights were returned to ARS in February 2023.
In the US, the company’s NDA for Neffy is currently under review by the FDA. The agency has set the PDUFA date for completion of the review as October 2, 2024.
ARS Pharma President and CEO Richard Lowenthal commented, “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, which improves outcome of allergic reactions.”
Read the ARS Pharmaceuticals press release.
