Pfizer's Paxlovid Scores FDA Approval, First Oral Antiviral For COVID-19 In US

The FDA has authorized the emergency use of Pfizer Inc's PFE Paxlovid (nirmatrelvir, PF-07321332) tablets and ritonavir tablets) for mild-to-moderate COVID-19 in adults and pediatric patients.

• The approval comes for patients aged 12 years and older weighing at least 40 kg, who are at high risk for progression to severe COVID-19, including hospitalization or death. 
• The emergency use nod is based on clinical data from EPIC-HR study, showing Paxlovid reduced risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo.
• Related: UK Calls For Additional Doses Of COVID-19 Antivirals From Merck, Pfizer.
• 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.
• Pfizer is also raising its production projections from 80 million to 120 million courses of Paxlovid by the end of 2022.
• Price Action: PFE shares are up 1.99% at $60.13 during the market session on the last check Wednesday.