Paxlovid FDA Approval Status
Paxlovid contains a novel antiviral (PF-07321332) which works by blocking the activity of the SARS-CoV-2-3CL protease, an enzyme that the coronavirus that causes COVID-19 needs to replicate. Co-administration with low dose ritonavir helps slow the metabolism of PF-07321332 allowing it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.
Paxlovid is administered orally every 12 hours for five days. Treatment should commence at the first sign of infection or at first awareness of an exposure, to potentially help patients avoid severe illness.
In an interim analysis of the Phase 2/3 EPIC-HR study, Paxlovid was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19. In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo.
Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA).
Nov 6, 2021
