FDA Nods to Pfizer's Paxlovid for COVID-19: A Potential $8 Billion Lifesaver in 2023

The FDA has approved Pfizer Inc's (NYSE:PFE) Paxlovid (nirmatrelvir and ritonavir) for mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
The FDA approval is based on safety and efficacy data from the EPIC clinical development program.
The Phase 2/3 EPIC-HR study enrolled unvaccinated, non-hospitalized adults aged 18 years and older with confirmed COVID-19 at increased risk of progressing to severe disease.
The data showed an 86% reduction in risk of COVID-19-related hospitalization or death from any cause through Day 28 in patients who initiated treatment with PAXLOVID within five days of symptoms onset, compared to placebo.
The FDA approval was further supported by the results from a secondary endpoint of the Phase 2/3 EPIC-SR study, which showed a numerical reduction in COVID-19-related hospitalizations or death from any cause through Day 28 in a sub-group of non-hospitalized adults, with confirmed COVID-19 who had at least one risk factor for progression to severe disease and who were fully vaccinated.
At this time, the U.S. government will continue to oversee the distribution of Paxlovid, and the U.S. residents eligible for Paxlovid will continue to receive the medicine at no charge.
Pfizer expects 2023 Paxlovid sales of $8 billion.
Price Action: PFE shares are down 2.18% at $37.79 on the last check Thursday.
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