Pfizer asks FDA for emergency approval of antiviral pill for treating COVID-19
Pfizer's clinical study of PAXLOVID showed an 89% reduction in risk of COVID-19-related hospitalization or death, the company says
Pfizer has submitted an application to the Food and Drug Administration for emergency use authorization of its antiviral pill PAXLOVID for the treatment of COVID-19, the pharmaceutical giant announced Tuesday.
The drug maker's study of the new antiviral showed nearly a 90% reduction in hospitalization and death for folks with coronavirus who took the pill versus those who did not.
"With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19," Pfizer CEO Albert Bourla said in a statement.
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"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," Bourla added.
Bourla told FOX Business' "Cavuto: Coast to Coast" earlier this month that the study involved unvaccinated people over the age of 18 who were not only diagnosed with COVID-19, but had comorbidities that made them more vulnerable to the virus such as obesity.
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The Pfizer chairman explained to host Neil Cavuto, "The treatment was done at home because these are pills, so this was really a game changer," adding that PAXLOVID "worked extremely well."
The FDA's response could come in a matter of weeks.
FOX Business' Talia Kaplan contributed to this report.