"Pfizer has applied to the Food and Drug Administration to authorize its antiviral pill to treat unvaccinated people with Covid-19 who are at high risk of becoming severely ill, the company said on Tuesday.
The drug, which will be sold under the brand name Paxlovid, could become available within weeks if authorization is granted. It is meant to be dispensed by pharmacies and taken at home.
Paxlovid is the second antiviral pill to show effectiveness against Covid, in a new class of treatments for the disease that are expected to reach far more patients than other drugs that are typically given by infusion.
In a key clinical trial, Paxlovid was found to sharply reduce the riskof hospitalization or death when given to high-risk unvaccinated volunteers soon after they started showing symptoms. It appears to be more effective than a similar offering from Merck, known as molnupiravir, that could be authorized as soon as early December.
Both pills are geared toward older people or people who have obesity or medical conditions that put them at elevated risk for getting severely ill from Covid.
A spokesman for Pfizer, Kit Longley, said that for now, the company is seeking authorization for its pill to be given only to unvaccinated people, but the company might submit amendments to that provision later, depending on the data from clinical trials."
The treatment, Paxlovid, is the second antiviral pill to show effectiveness in treating Covid.
www.nytimes.com
Here's the release from Pfizer -
If approved or authorized, PAXLOVID™ (PF-07321332; ritonavir) would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2 EUA submission includes clinical data from an interim analysis of the Phase 2/3 EPIC-HR study, which demonstrated an...
investors.pfizer.com