FDA Approves Paxlovid: The First Oral Antiviral for Treating COVID-19 in High-Risk Adults

On May 25, 2023, the U.S. Food and Drug Administration (FDA) approved Paxlovid, the first oral antiviral pill for treating mild-to-moderate COVID-19 in high-risk adults. This is a major development in the fight against COVID-19, as Paxlovid marks the fourth FDA-approved drug for COVID-19 treatment in adults.

Manufactured under an Emergency Use Authorization (EUA), Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) is distributed by the U.S. Department of Health and Human Services. It will continue to be accessible for adults and eligible children aged 12-18 who are not covered by the current approval. Paxlovid is not approved or authorized for use as a preventative measure for COVID-19 exposure.

Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research, acknowledged the progress made during the challenging pandemic times. She confirmed that Paxlovid met the FDA’s rigorous safety and effectiveness standards, proving to be a vital treatment for individuals at a high risk of progressing to severe COVID-19, including those with prior immunity.

The FDA approval follows a benefit-risk assessment based on strict scientific standards. These evaluations ensure the benefits of a new drug outweigh the risks for the intended population.

Supporting the efficacy of Paxlovid is the EPIC-HR clinical trial. This study was a randomized, double-blind, placebo-controlled trial of Paxlovid for non-hospitalized symptomatic adults with a laboratory-confirmed diagnosis of SARS-CoV-2 infection. It found that Paxlovid significantly reduced COVID-19 related hospitalization or death by 86% compared to placebo when patients were treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment.

Importantly, Paxlovid also showed benefit in patients with prior immunity to the virus causing COVID-19. In the EPIC-HR trial, among patients with antibodies at the time of enrollment, the risk of COVID-19-related hospitalization or death during 28 days of follow-up was significantly lower for Paxlovid-treated patients compared to those receiving a placebo.

There are potential drug-drug interactions with Paxlovid, and therefore, the approved label and authorized Fact Sheet come with a boxed warning for prescribers. Doctors need to review all medications the patient is taking to assess potential interactions and decide if the patient’s other medications require a dose adjustment or interruption and/or additional monitoring.

The FDA has supplied all prescribers with vital information for Paxlovid prescription, including dosing instructions, potential side effects, and drugs that may cause interactions. The most common side effects of Paxlovid include an impaired sense of taste and diarrhea.

This approval of Paxlovid provides a new and promising treatment option for COVID-19, marking a significant step forward in managing the ongoing pandemic.