FDA AMDAC votes to support Paxlovid for use in COVID-19.- Pfizer

The AMDAC's vote, while not binding, will be considered by the FDA when making its decision regarding the potential approval of Paxlovid.

The AMDAC based its vote on the totality of scientific and real-world evidence shared by Pfizer, including safety and efficacy data from the EPIC (Evaluation of Protease Inhibition for COVID-19) clinical development program. This included results from the Phase II/III EPIC-HR study (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients), which enrolled unvaccinated, non-hospitalized adults, aged 18 years and older, with confirmed COVID-19 who are 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 treated with Paxlovid within 5 days of symptoms onset, compared to placebo. The vote was further supported by results from a secondary endpoint of the Phase II/III EPIC-SR study (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) which showed the effectiveness of Paxlovid in a sub-group of non-hospitalized adults, aged 18 years and older, with confirmed COVID-19 who had at least one risk factor for progression to severe disease and who were fully vaccinated.

In addition, real-world evidence presented to the AMDAC showed that Paxlovid’s clinical profile in the post-authorization setting is consistent with the safety and efficacy conclusions from the EPIC clinical program, including observations made when the Omicron variant and its lineages were the predominant forms of SARS-CoV-2 in circulation. This real-world evidence also shows the effectiveness of Paxlovid among vaccinated patients and patients who developed natural immunity.