New York—The FDA is reviewing two promising oral antiviral drugs as additional weapons to combat SARS-CoV-2.
Pfizer Inc. sought Emergency Use Authorization (EUA) for PF-07321332; ritonavir, marketed as Paxlovid in mid-November. The EUA submission includes clinical data from an interim analysis of the phase II/III EPIC-HR study. That trial documented an 89% reduction in risk of COVID-19-related hospitalization or death compared with placebo in nonhospitalized high-risk adults with COVID-19.
If approved, pharmacies should find the supply adequate. Media reports suggest that the Biden Administration is planning to purchase 10 million courses of Pfizer’s covid pill. That will require a $5 billion investment but also holds out the promise of reducing severe illness and death with about 30% of adults not fully vaccinated and breakthrough cases on the increase. Pfizer has already started manufacturing the drug and reportedly will produce enough to provide adequate doses to 100,000 to 200,000 people by the end of the year, with millions more to come in the first half of 2022.
In a similar deal for Merck and Ridgeback Biotherapeutics' COVID drug molnupiravir, which the FDA is already reviewing, the federal government has agreed to pay about $2.2 billion for 3.1 million courses of that drug if okayed. The companies filed for EUA in October.
If authorized or approved, Pfizer notes that Paxlovid would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2. The drug is intended to be prescribed as an at-home treatment to high-risk patients at the first indication of infection, with the goal of helping to avoid severe illness.
“With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” said Albert Bourla, Pfizer’s chairman and CEO. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world.”
The EPIC-HR interim analysis, which enrolled nonhospitalized adults aged 18 years and older with confirmed COVID-19 who are at increased risk of progressing to severe illness, demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death from any cause in patients treated with Paxlovid compared with placebo within 3 days of symptom onset. No deaths occurred in the treatment group. The company reports that similar results were seen within 5 days of symptom onset.
The study also found that treatment-emergent adverse events were comparable between Paxlovid (19%) and placebo (21%), and most were mild.
Because of evidence of overwhelming efficacy, enrollment in the study was ceased at the recommendation of an independent Data Monitoring Committee and in consultation with the FDA, Pfizer says.
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