Pfizer’s Covid-19 pill gets U.S. FDA clearance
Drug Approval

Pfizer’s Covid-19 pill gets U.S. FDA clearance

Pfizer raises production projections from 80 million to 120 million courses of treatment in 2022, as a result of continued investments to support the manufacturing and distribution of Paxlovid

  • By IPP Bureau | December 23, 2021

Pfizer announced that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of paxlovid (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate Covid-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe Covid-19, including hospitalization or death. The treatment includes nirmatrelvir, a novel main protease inhibitor originating in Pfizer’s laboratories, which was specifically designed to block the activity of the SARS-CoV-2 an enzyme that the coronavirus needs to replicate. 

“Today’s authorization of Paxlovid represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world. This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat Covid-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Pfizer stands ready to begin delivery in the U.S. immediately to help get Paxlovid into the hands of appropriate patients as quickly as possible.”

With Paxlovid now authorized for emergency use, Pfizer stands ready to start delivery in the U.S. immediately. In November 2021, Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses of Paxlovid, with delivery fulfillment expected to be completed in 2022.

 

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