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

The FDA rejected approval for Neffy, the first needle-free epinephrine nasal spray alternative to EpiPens, requesting more research.
The rejection came despite an FDA advisory committee voting to recommend approval in May.
The company plans to appeal and provide more data, surprised by the FDA's decision.
Some doctors expressed shock at the rejection, though an advisory committee member cited lack of data in people with anaphylaxis.
The drugmaker plans to resubmit its application in 2024 after an additional study comparing Neffy to an epinephrine autoinjector.

nbcnews.com

Relevant topic timeline:

9/20/2023

FDA Declines Approval of First Needle-Free Epinephrine Nasal Spray Neffy, Cites Need for More Data

The US Food and Drug Administration has not approved a needle-free epinephrine treatment for severe allergic reactions, requesting additional information about the nasal spray instead.

9/20/2023

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

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