The U.S. Food and Drug Administration (FDA) has approved Paxlovid (nirmatrelvir and ritonavir tablets) for treatment of mild-to-moderate COVID-19 in patients who are at the highest risk of severe illness, according to a release issued May 25.
The antiviral is the first oral medication FDA has approved, and the fourth to treat COVID-19 in adults, the FDA said.
“While the pandemic has been challenging for all of us, we have made great progress mitigating the impact of COVID-19 on our lives," Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in the release. "Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity. The FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19.”
According to the Federal Food, Drug, and Cosmetic Act, approval of a novel drug is contingent on strong proof of its efficacy and a demonstration of its safety when used as intended. The FDA conducts a benefit-risk analysis on each product to decide whether each product would be beneficial to its target market, the release stated.
Paxlovid was being studied in the randomized, double-blind, placebo-controlled clinical trial known as EPIC-HR for the treatment of patients who suffered from COVID but had not been hospitalized. The patients were all adults who had never been vaccinated, the FDA reported.
Paxlovid "significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause through 28 days of follow-up" in 86% of those studied, compared to unvaccinated, placebo patients who were treated within five days of the onset of symptoms, according to the study.
Paxlovid which was available under the emergency use authorization and distributed by the Department of Health and Human Services will still be available for adults and eligible children ages 12-18 who are not covered by the FDA's approval.
