Pfizer has applied for emergency use authorization from the FDA for its COVID-19 antiviral pill Paxlovid, the drugmaker announced Nov. 16.
Paxlovid reduced the risk of hospitalization or death by 89 percent in a phase 3 trial, according to a news release.
The pill is made up of two components, an experimental molecule called PF-07321332 and an HIV antiviral drug called ritonavir. Both components are protease inhibitors, meaning they block an enzyme that cuts apart long strands of nonfunctional viral proteins into smaller, functional proteins.
"The overwhelming efficacy achieved in our recent clinical study of Paxlovid, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19," Pfizer CEO Albert Bourla, PHD, said in the release. "We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world."
Pfizer's application comes about a month after Merck asked the FDA for emergency use authorization of molnupiravir, the COVID-19 antiviral pill it is developing with Ridgeback Biotherapeutics. Both Merck and Pfizer have signed licensing deals that allow other drugmakers to manufacture their COVID-19 antiviral pills.