According to ARS Pharmaceuticals, the FDA has extend the PDUFA target date for completion of its review of ARS’s NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions. The agency accepted the NDA for review in October 2022 and at that time, ARS said that the PDUFA date had been set for “mid-2023.” The company says that the new PDUFA date is September 19, 2023.
In May 2023, the FDA’s Pulmonary-Allergy Drug Advisory Committee (PADAC) voted that the data supported a favorable risk/benefit assessment for the use of Neffy in both adults and children. On June 14, 2023, Endpoints News and Citeline’s Pink Sheet reported that EpiPen maker Viatris had filed a citizen petition requesting the FDA require ARS to perform additional PK/PD studies. ARS says that the FDA has not requested any additional studies, and that “ARS has addressed all other information requests from the Agency to date.” The company also notes that it has submitted post-marketing commitment proposals.
ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “FDA is working on labeling and post-marketing commitments as the final steps in the review process. Following the strong endorsement of our clinical data for Neffy at the May PADAC meeting, there was limited time to address any final questions and complete labeling. While the Agency extended the PDUFA timeline, we are hopeful that labeling discussions will be completed as soon as possible given the significant unmet need in the allergy community for a needle-free option that is easily carried and administered without anxiety or hesitation.”
The company also said that the EMA is expected to complete its review of ARS’s MAA for Neffy early next year. The agency accepted the MAA for review in October 2020.
Read the ARS Pharmaceuticals press release.
