FDA Grants Full Approval to Paxlovid to Treat COVID-19

THURSDAY, May 25, 2023 (HealthDay News) — Americans with COVID-19 have been taking Paxlovid (nirmatrelvir tablets and ritonavir tablets, copackaged for oral use) since it was approved under emergency use in late 2021. Today, the U.S. Food and Drug Administration granted full approval to the drug. This approval will allow drugmaker Pfizer to sell the medication at market rate once government supplies are used up.

Paxlovid is the fourth antiviral drug and first pill approved by the FDA to treat COVID-19. It is meant to keep at-risk adults from progressing to severe COVID-19 symptoms, including hospitalization and death.

The approval was made using results from the randomized EPIC-HR clinical trial. The trial studied adults who had a lab-confirmed COVID-19 infection and symptoms but were not hospitalized. They each had a risk factor for severe disease, such as obesity or diabetes, or were 60 years and older. These patients had not received a COVID-19 vaccine or been infected before.

In total, 977 patients received Paxlovid and another 989 patients received a placebo. Among those who received the placebo, 6.5 percent were hospitalized or died compared with 0.9 percent who received Paxlovid during 28 days of follow-up. The researchers found that Paxlovid reduced odds of hospitalization or death by 86 percent compared with those given a placebo within five days of symptom onset. The patients also did not receive monoclonal antibody treatment.

In patients who had COVID-19 antibodies at the start of the EPIC-HR trial, the risk for COVID-19-related hospitalization or death from any cause during 28 days of follow-up was 0.2 percent among the 490 patients treated with Paxlovid compared with 1.7 percent of the 479 patients who received the placebo.

The medication’s label will come with a boxed warning with instructions for prescribers because of some interactions with other medications. Prescribers will need to review these and decide whether patients can still take Paxlovid with some dose adjustments or additional monitoring. Although the approval is for adult use, the medication will continue to be available under emergency use authorization for those ages 12 to 18 years.