FDA approves first oral antiviral for treatment of COVID-19 in adults
The Food and Drug Administration has approved Pfizer's oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.
Paxlovid manufactured and packaged under the emergency use authorization and distributed by the Department of Health and Human Services will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by today's approval.
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Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
"While the pandemic has been challenging for all of us, we have made great progress mitigating the impact of COVID-19 on our lives," said Patrizia Cavazzoni, director for the FDA's Center for Drug Evaluation and Research.
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Cavazzoni added, "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."
“Great advancements have been made in the fight against COVID-19, yet the virus remains a present and unpredictable concern. This is especially true for the hundreds of millions of American adults who are age 50 or older or are otherwise at high risk for progression to severe illness, even if symptoms are initially mild,” said Albert Bourla, chairman and CEO of Pfizer. “Today marks a monumental milestone as Paxlovid became the first COVID-19 oral treatment to be approved by the U.S. FDA, underscoring the value it brings to patients, providers and health systems alike.”
COVID-19 continues to cause significant burden in the U.S. with approximately 14,500 reported cases each week as of the end of April 2023; but the majority of cases are not reported. In addition, data show that the impact of COVID-19 extends beyond an acute infection; an estimated 10-31 million Americans may experience persisting, recurring or new symptoms after the acute phase of COVID-19 infection, Pfizer said.