“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, M.D., Ph.D of FDA’s CDER.
Tag Archive for: neffy
The U.S. health regulator has declined to approve a nasal spray that would have been the first needle-free emergency treatment for allergic reactions, a surprise decision that sent shares of its developer ARS Pharmaceuticals down 47% premarket.
Despite concerns regarding neffy’s lack of clinical evidence, the panel of experts voted in favor of the nasal spray’s approval for the emergency treatment of type 1 allergic reactions.
The FDA is kicking off May with three target action dates and three advisory committee meetings, including one for a high-profile investigational gene therapy.