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Viatris Asks FDA Not To Approve Neffy Until Sponsor Conducts More PK/PD Studies

 
• By Brenda Sandburg

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.

Anaphylaxis
Viatris says intranasal spray for treatment of anaphylaxis requires more PK/PD studies for approval • Source: Shutterstock

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

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