FDA grants EUA for Pfizer’s COVID-19 pill

Pfizer Inc. has announced that the US Food and Drug Administration (FDA) has authorised the emergency use of PAXLOVID (nirmatrelvir 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) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalisation or death. The treatment includes nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer’s laboratories, which was specifically designed to block the activity of the SARSCoV-2 Mpro, an enzyme that the coronavirus needs to replicate. With PAXLOVID now authorised for emergency use, Pfizer stands ready to start delivery in the US 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.