The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) recently announced that there was a 16-to-1 vote indicating that available data support the safety and effectiveness of Paxlovid (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adult patients who are classified as being at high risk for progression to severe illness. While not binding, the AMDAC’s vote will be considered by the FDA when deciding on the potential approval of nirmatrelvir tablets and ritonavir tablets.
The AMDAC Committee established its vote on the totality of scientific and real-world evidence communicated by Pfizer, including safety and efficacy data from the EPIC (Evaluation of Protease Inhibition for COVID-19) clinical development program. This data involved results from the phase II/III EPIC-HR study (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients), which enrolled unvaccinated, nonhospitalized adults aged 18 years and older with confirmed COVID-19 who are at increased risk of progressing to severe disease. The data demonstrated an 86% decrease in risk of COVID-19-related hospitalization or mortality from any cause through Day 28 in patients treated with Paxlovid within 5 days of symptoms onset, compared with placebo.
The vote was additionally supported by results from a secondary endpoint of the phase II/III EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) study, which revealed the effectiveness of Paxlovid tablets in a subgroup of nonhospitalized 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 Committee revealed that the clinical profile of Paxlovid tablets in the postauthorization 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 demonstrates the effectiveness of Paxlovid tablets among vaccinated patients and patients who developed natural immunity.
James Rusnak, senior VP and chief development officer, internal medicine, anti-infectives and hospital, Pfizer, stated, “We believe it is critical for adults who are at high risk of progression to severe COVID-19 to have access to safe and effective treatment options, like Paxlovid, to help prevent avoidable hospitalizations and deaths. We are encouraged by the AMDAC’s positive vote today. The outcome is well supported by the strong safety and efficacy data seen both in our clinical trials and in a growing base of real-world evidence, showing that Paxlovid helps to reduce the risk of hospitalization or death for high-risk adult patients regardless of vaccination status.”
If approved by the FDA, Paxlovid tablets could be the first FDA-approved oral treatment for COVID-19, and the projected target Prescription Drug User Fee Act action date for a decision by the FDA is May 2023. Under the FDA emergency use authorization, Paxlovid is currently authorized for use in and remains accessible to adults and pediatric patients (aged 12 years and older weighing at least 40 kg) at high risk of progression to severe COVID-19. In the United States, more than 10 million treatment courses of Paxlovid tablets have been prescribed to date.
The manufacturer continues to accumulate pediatric data from the ongoing EPIC-Peds (Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients) clinical trial and intends to submit a supplemental New Drug Application to support the FDA approval of Paxlovid tablets in pediatric patients at a future date.
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