The Food and Drug Administration has given full approval for the COVID-19 antiviral Paxlovid to treat adults at high risk of severe disease.
Paxlovid, a combination of the drugs nirmatrelvir and ritonavir, received emergency use authorization in December of 2021 and continues to be an effective treatment for COVID-19, the agency said in an announcement on Thursday. It also remains one of handful of treatments available for the disease.
In clinical trials, Paxlovid given within five days of symptom onset reduced the risk of hospitalization or death from any cause by 86% through 28 days of follow-up when compared to placebo.
Paxlovid comes with boxed warnings for potential drug-drug interactions. Clinicians should weigh the risks and benefits of reduced hospitalization and death and whether a patient’s medications should be adjusted while it is in use, the FDA noted.
“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, MD, director for the FDA’s Center for Drug Evaluation and Research, said in a statement.
Efficacy in seniors
The treatment has also been found to be very effective in seniors. An Israeli investigation published in June 2022 found that both vaccinated and unvaccinated seniors with COVID-19 have lower rates of hospitalization and death when taking the drug. A seven-month study in a large hospital system found that, although the overall risk for hospitalization or death for study participants was already very low (1%), Paxlovid reduced that risk by another 44%.
New vaccine in the wings
In related COVID-19 news, drugmaker BioNTech said that it and its partner Pfizer should have a new COVID-19 vaccination ready for the fall that will be adapted to the dominant circulating virus, Reuters has reported. The World Health Organization has recommended that vaccine makers focus on developing a booster shot that will target the XBB variant.
Related articles:
FDA advisers support full approval of Paxlovid for at-risk older adults
Paxlovid cuts seniors’ COVID-19 risk, no matter their vaccine status: study
Seven-month study supports benefits of COVID-19 antivirals in seniors
