(HealthDay News) — The US Food and Drug Administration (FDA) has granted full approval to Paxlovid (nirmatrelvir tablets and ritonavir tablets, copackaged for oral use) for the treatment of COVID-19.
Americans have been taking Paxlovid since it was granted emergency use authorization in late 2021. The full approval will allow the drugmaker, Pfizer, to sell Paxlovid 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, leading to hospitalization and death.
The approval was supported by results from the randomized EPIC-HR trial. The trial included adults who had a lab-confirmed SARS-CoV-2 infection and symptoms but were not hospitalized. They each had a risk factor for severe COVID-19, 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. The rate of hospitalization or death at 28 days was 6.5% in the placebo arm and 0.9% in the Paxlovid arm. The researchers found that Paxlovid reduced the odds of hospitalization or death by 86% compared with placebo.
In patients who had COVID-19 antibodies at the start of the EPIC-HR trial, the risk of COVID-19-related hospitalization or death from any cause during 28 days of follow-up was 0.2% in the 490 patients treated with Paxlovid and 1.7% of the 479 patients who received placebo.
Paxlovid’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 patients ages 12 to 18 years.