FDA Rejects Approval for Neffy, Nasal Spray Alternative to EpiPen, Despite Advisory Committee Backing

The FDA surprisingly declined to approve neffy, a nasal spray alternative to the EpiPen, requesting more study first.
Neffy was expected to be approved after an FDA advisory committee recommended approval in a 16-6 and 17-5 vote.
People with severe allergic reactions currently can only use epinephrine autoinjectors like EpiPen. Neffy was seen as a more convenient, needle-free option.
The maker of neffy plans to appeal the FDA's decision, which is rare when going against an advisory committee recommendation.
An advisory committee member voted against neffy, citing lack of data in patients actually experiencing anaphylaxis and concerns about effectiveness.

deseret.com

Relevant topic timeline:

9/20/2023

FDA Rejects Approval for Needle-Free Epinephrine Nasal Spray Neffy, Requests More Research

The Food and Drug Administration rejects ARS Pharmaceuticals' epinephrine nasal spray, Neffy, the first needle-free alternative to epinephrine autoinjectors, requesting additional data and clinical studies before potential approval.