FDA approves Paxlovid as treatment for adults at high risk for severe COVID-19
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Key takeaways:
- The FDA has granted full approval for Paxlovid in adults at high risk of severe COVID-19.
- Paxlovid is the first oral antiviral pill approved by the FDA to treat COVID-19 in adults.
The FDA on Thursday granted full approval for Paxlovid, making it the first oral antiviral pill approved by the FDA to treat COVID-19 in adults.
“While the pandemic has been challenging for all of us, we have made great progress mitigating the impact of COVID-19 on our lives,” Patrizia Cavazzoni, MD, director for the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”
Paxlovid was initially granted an emergency use authorization (EUA) in December 2021 for use in high-risk people aged 12 years and older. Shortly after that, in July 2022, the FDA expanded the EUA to allow pharmacists to prescribe the drug to qualifying people immediately after testing positive for the virus.
More recently, the FDA’s Antimicrobial Drugs Advisory Committee voted 16-1 in support of the approval of Paxlovid for the treatment of mild-to-moderate COVID-19 in adults at high risk for severe disease, hospitalization or death. Votes were based on data from three phase 2/3 trials presented to the committee that demonstrated no major safety concerns — although there were risks for serious adverse reactions from to drug-drug interactions. Additional data presented to the committee also showed there was no association between Paxlovid and “rebound” COVID-19.
Paxlovid’s efficacy was also evaluated and supported primarily by the results of the EPIC-HR clinical trial, according to the FDA.
EPIC-HR, a randomized, double-blind, placebo-controlled clinical trial, studied Paxlovid for the treatment of nonhospitalized symptomatic adults with a laboratory confirmed COVID-19. Overall, it demonstrated that Paxlovid significantly reduced the proportion of people with COVID-19-related hospitalization or death from any cause through 28 days by 86% compared with placebo among patients treated within 5 days of symptom onset.
No changes have been made regarding approvals of Paxlovid for children aged 12 years or older. The FDA previously said that the EUA for this age group will remain in place.
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