Pfizer submits FDA application for emergency approval of Covid treatment pill
Pfizer CEO Albert Bourla addresses a press conference after a visit to oversee the production of the Pfizer-BioNtech COVID-19 vaccine at the factory of U.S. pharmaceutical company Pfizer in Puurs, Belgium April 23, 2021.
John Thys | Pool | Reuters
Pfizer on Tuesday submitted its application to the Food and Drug Administration for emergency authorization of its Covid-19 treatment pill.
The pill, if authorized by the FDA, would be the first oral antiviral drug of its kind specifically designed to combat Covid, according to the company.
Known as Paxlovid, the pill cut the risk of hospitalization from Covid by 89% in high-risk adults who were exposed to the virus when taken in combination with a widely used HIV drug, according to the company.
“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 CEO Albert Bourla said in a statement Tuesday.
Bourla had previously said that Pfizer planned to submit its data to the FDA before Thanksgiving.
Earlier Tuesday, Pfizer announced that it would allow generic manufacturers to supply its antiviral pill, known as Paxlovid, to 95 low and middle-income countries.
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