FDA advisory committee votes in support of Pfizer’s Paxlovid
The Food and Drug Administration’s Antimicrobial Drugs Advisory Committee has voted 16 to 1 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 at high risk for progression to severe illness.
The AMDAC's vote, while not binding, will be considered by the FDA when deciding on the potential approval of Paxlovid.
Paxlovid is a SARS-CoV-2 main protease inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It was developed to be orally administered so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir, which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir for it to remain active in the body for longer periods at higher concentrations to help combat the virus, the company said.
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“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,” said James Rusnak, senior vice president and chief development officer, internal medicine, anti-infectives and hospital at Pfizer. “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 could be the first U.S. FDA-approved oral treatment for COVID-19. The target Prescription Drug User Fee Act action date for a decision by the FDA is May 2023.
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Under the FDA emergency use authorization, Paxlovid is currently authorized for use in and remains available to adults and pediatric patients (12 years of age 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 have been prescribed to date.