Pfizer submits FDA application for emergency approval of Covid treatment pill

Pfizer CEO Albert Bourla speaks at a press conference following a visit to monitor the production of the Pfizer-BioNtech COVID-19 vaccine at the factory of the American pharmaceutical company Pfizer in Puurs, Belgium on April 23, 2021.

John Thys | Pool | Reuters

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

The pill, if approved 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 reduced 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 efforts to get this potential treatment in the hands of patients, and we look forward to working with the US FDA on its review of our application, along with other regulatory agencies around the world. , “Pfizer” said CEO Albert Bourla in a statement on 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 their antiviral pill, known as Paxlovid, to 95 low- and middle-income countries.

This is breaking news. Please come back for updates.


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