EpiPen maker says available evidence does not answer questions about how an intranasal epinephrine from ARS Pharmaceuticals will perform in a real-world anaphylaxis event. Viatris citizen petition argues issues raised at advisory committee were not resolved.
Viatris Inc. contends that there are unanswered questions about the real-world use of ARS Pharmaceuticals, Inc.’s intranasal epinephrine neffy (ARS-1) to treat anaphylaxis and that the US Food and Drug Administration should require the sponsor to conduct additional pharmacokinetic and pharmacodynamic studies before approving the drug.
Viatris’s Mylan Specialties, which holds the new drug application for EpiPen (epinephrine injection) and EpiPen Jr., submitted a citizen...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
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Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
