Pfizer submits FDA application for emergency approval of Covid treatment pill

Albert Burla, CEO of Pfizer, speaks at a press conference after a visit to oversee production of the Pfizer-BioNtech COVID-19 vaccine at the US pharmaceutical company Pfizer’s plant in Bourse, Belgium on April 23, 2021.

John Theiss | pool | Reuters

Pfizer on Tuesday submitted its application to the Food and Drug Administration for emergency authorization of its Covid-19 treatment pills.

The company said the pill, if permitted by the Food and Drug Administration, would be the first oral antiviral drug of its kind designed specifically to combat Covid.

The birth control pill, known as Paxlovid, reduces the risk of hospitalization from Covid by 89% in high-risk adults who have been exposed to the virus when taken with the widely used HIV drug, according to the company.

“We are moving as quickly as possible in our efforts to get this potential treatment into patients’ hands, and we look forward to working with the U.S. Food and Drug Administration on its review of our application, along with other regulatory agencies around the world,” Pfizer CEO Albert Burla said in a statement Tuesday.

Burla had previously said that Pfizer plans to submit its data to the Food and Drug Administration before Thanksgiving.

Earlier Tuesday, Pfizer announced that it would allow generic drug manufacturers to supply 95 low- and middle-income countries with its antiviral pill, known as Paxlovid.

This is urgent news. Please check back for updates.


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