Pfizer Seeks EUA for COVID-19 Oral Antiviral

Pfizer has filed its application with the FDA for Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, Paxlovid, for the treatment of mild-to-moderate COVID-19 in patients at increased risk of hospitalization or death.

Earlier this month, an interim analysis of a phase 2/3 study showed that the drug cut the risk of COVID-19-associated hospitalizations and death by 89 percent compared to placebo. The study was stopped due to “overwhelming efficacy,” the company said.

If approved, Paxlovid would be the first oral antiviral of its kind — a 3CL protease inhibitor — that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness.