Pfizer’s Paxlovid authorized for emergency use to treat Covid individuals at high risk, gets the nod from US FDA

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Pfizer, on Wednesday, announced that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of Paxlovid for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients.

Pfizer’s Paxlovid is a combination of nirmatrelvir tablets and Ritonavir tablets, co-packaged for oral use. The drugs can be administered to covid positive individuals who are at high risk for progression to severe COVID-19, including hospitalization or death.

“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.”

Albert Bourla, Chairman and Chief Executive Officer, Pfizer

He adds, “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.”

In the case of pediatric patients, the individual should be at least 12 years of age and 40 kilograms in terms of weight to get the medicine. The treatment includes nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer’s laboratories, which was specifically designed to block the activity of an enzyme (SARS-CoV-2 Mpro) that the coronavirus needs to replicate. 

Pfizer is ready to begin delivery in the United States as soon as PAXLOVID is approved for emergency use. Pfizer stated in November 2021 that it has reached an agreement with the US government to supply 10 million PAXLOVID therapy courses, with delivery scheduled in 2022.

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