According to Silverback Therapeutics and ARS Pharmaceuticals, the FDA has accepted ARS’s NDA for its Neffy intranasal epinephrine for the treatment of allergic reactions, including anaphylaxis, with a PDUFA date set for mid-2023. The two companies recently announced that they would merge, with the resulting company operating as ARS Pharmaceuticals and focused on potential commercialization of Neffy. The merger is expected to close by the end of this year.
The FDA granted Fast Track designation to the epinephrine nasal spray, then called ARS-1, in February 2019. In Europe, Recordati acquired marketing rights to Neffy in the EU and a number of other countries in September 2020, and ARS submitted an MAA for Neffy to the EMA in November of that year.
ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “The FDA acceptance of our NDA for Neffy is a major milestone in our efforts to bring to patients the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but in a needle-free and simple to administer nasal spray. We appreciate that the FDA recognizes the potential clinical benefit of this novel approach to treating patients with severe allergies and look forward to working with the FDA during this process, with the goal of potentially changing the treatment paradigm for the millions of patients with or at-risk for severe allergic reactions (type I).”
Read the Silverback Therapeutics press release.
