Pfizer COVID antiviral gets FDA EUA

Dec. 22, 2021

Pfizer announced that the U.S. FDA has authorized the emergency use of Paxlovid tablets for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years and older — making it the first at-home COVID treatment to get an FDA blessing.

Last week, Pfizer shared final results from an analysis of 2,246 adults enrolled in its phase 2/3 EPIC-HR trial of the novel oral antiviral candidate. Final data available from all high-risk patients enrolled showed that Paxlovid reduced risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo. Recent lab data suggests the drug retains its effectiveness against Omicron, Pfizer said.

The two-drug co-packaged regimen includes a novel main protease inhibitor developed by Pfizer, called nirmatrelvir, and a low dose of a second older antiviral, ritonavir. The treatment is available by prescription only and is designed to be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

Pfizer said it is ready to start delivery in the U.S. immediately. In November, the drugmaker announced an agreement with the U.S. government to supply 10 million treatment courses, with delivery fulfillment expected to be completed in 2022. Reuters reports that the government's contract for 10 million courses of the treatment is priced at $530 per course.

The drugmaker says it has submitted applications for regulatory approval or authorization to multiple regulatory agencies around the world and anticipates further regulatory decisions to follow. Pfizer also plans to file a New Drug Application with the FDA in 2022 for potential full regulatory approval.