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.

• Photo via Wikimedia Commons

 

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This article FDA Nods to Pfizer's Paxlovid for COVID-19: A Potential $8 Billion Lifesaver in 2023 originally appeared on Benzinga.com

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