On Friday, the Food and Drug Administration approved the first needle-free treatment for adults and kids with severe allergic reactions. The approval introduces a competitor from ARS Pharma to older epinephrine products, like the EpiPen.
Neffy, as the product is called, is a nasal spray that delivers the same drug used to treat anaphylaxis. It is ARS’ flagship product. Friday’s approval comes after the FDA stalled neffy’s approval in September, asking the drugmaker for additional data.
At the time, the company was being asked to conduct a repeat-dose study of neffy to show it worked as well as available epinephrine products. (Viatris, the maker of the EpiPen, also filed a petition asking for more data, Endpoints reported.) Much of the data ARS submitted last year was from people who were healthy or only had mild allergies (not anaphylaxis), there was limited safety data, no formal clinical efficacy trial, and results varied across trials.
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