Medication is the first in pill form to receive approval
The U.S. Food and Drug Administration (FDA) has fully approved Paxlovid for treatment of COVID-19 in adults. It is the fourth drug, and first the first in the form of a pill, approved for that purpose.
In its May 25 announcement, the FDA said the approval is for adults with mild-to-moderate cases who are at high risk of progressing to severe COVID-19, including hospitalization and death.
“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,” Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research said in a news release.
The FDA had granted temporary emergency use authorization (EUA) to Paxlovid late in 2021. Since then more than 11.6 million prescriptions for the drug have been written in the U.S., according to Pfizer, its manufacturer.
“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,” Albert Bourla, Pfizer’s chairman and CEO, said in a separate news release.
The FDA said its approval was primarily based on results of a randomized, double-blind, placebo-controlled clinical trial studying Paxlovid for the treatment of non-hospitalized symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2 infection.
Paxlovid manufactured and packaged under the EUA and distributed by the U.S. Department of Health and Human Services will continue to be available to adults and for treatment of eligible children ages 12-18 not covered by the approval, the FDA said.
The FDA is providing all prescribers information for prescribing Paxlovid properly and safely, such as dosing instructions, potential side effects and information regarding drugs that may cause drug-drug interactions with Paxlovid.