STAT+: Approval setback for EpiPen alternative puts spotlight on common anti-competition tactic
"Citizen petition abuse can cost consumers billions of dollars a year in lost savings," said Robin Feldman, a professor at University of California Law, San Francisco.
Americans who suffer severe allergic reactions won’t have alternatives to auto-injectors like the EpiPen for a while longer. In a surprise move, the Food and Drug Administration on Tuesday declined to approve neffy, an epinephrine nasal spray. Instead, the FDA asked the drug’s manufacturer, ARS Pharma, to conduct further studies, specifically comparing the effect of repeat doses of epinephrine administered via nasal spray versus auto-injection in people with allergic rhinitis, or hay fever.
This was unexpected, and disappointing, for ARS Pharma: In May, an FDA advisory committee had voted 16-6 in favor of neffy’s approval for adults, and 17-5 in favor for children. But there is at least one party that’s likely to benefit from this development: Viatris, the maker of EpiPen, the brand-name epinephrine auto-injector used to treat anaphylaxis. (A generic version is also available, made by Teva).
In June, Viatris filed a citizen petition with the FDA, saying that the available evidence left doubts about how neffy would actually perform in a real-life anaphylactic event compared to auto-injectable epinephrine.
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