Pfizer to ask the FDA, international regulators for authorization of use

Pfizer Inc. said Friday that its experimental antiviral pill for COVID-19 cut rates of hospitalization and death by nearly 90% in high-risk adults, as the drugmaker joined the race for an easy-to-use medication to treat the coronavirus.

Currently most COVID-19 treatments require an IV or injection. Competitor Merck’s COVID-19 pill is already under review at the Food and Drug Administration after showing strong initial results, and on Thursday the United Kingdom became the first country to OK it.

A moment in time somewhere on the Bowery

Pfizer said it will ask the FDA and international regulators to authorize its pill as soon as possible, after independent experts recommended halting the company’s study based on the strength of its results. Once Pfizer applies, the FDA could make a decision within weeks or months.

A Pfizer sign hangs on the outside of their headquarters after a news conference discussing the planned merger of Pfizer and Wyeth January 26, 2009 in New York City. (Photo by Mario Tama/Getty Images)

Since the beginning of the pandemic last year, researchers worldwide have been racing to find a pill to treat COVID-19 that can be taken at home to ease symptoms, speed recovery and keep people out of the hospital.

Having pills to treat early COVID-19 “would be a very important advance,” said Dr. John Mellors, chief of infectious diseases at the University of Pittsburgh, who was not involved in the Pfizer study.

Source: Pfizer says COVID-19 pill cut hospital, death risk by 90%