(CNN) — The US Food and Drug Administration (FDA) advisers voted 16-1 this Thursday in favor of approving Paxlovid, stating that the benefits outweigh the dangers of the drug to treat covid -19 in high-risk adults, when the disease is mild to moderate and may progress to a serious condition, including hospitalization and death.
“I would say that other than oxygen, Paxlovid has probably been the most important tool in this epidemic, and it continues to be,” said Dr. Richard Murphy, chief of infectious diseases at White River Junction Veterans Affairs Medical Center and a member of the committee. FDA Antimicrobial Drug Advisor who voted in favor of authorization.
“We still have many groups that will benefit from the use of Paxlovid, including the unvaccinated, the incompletely vaccinated, the elderly, the immunosuppressed. And the other available treatment options have significant drawbacks,” Murphy added.
The data presented showed that patients receiving Paxlovid benefited regardless of vaccination status, prior infection, or whether the covid-19 infection was omicron variant or an earlier variant.
“I thought the efficacy data was clear and compelling,” said Dr. Sankar Swaminathan, chief of infectious diseases at the University of Utah School of Medicine, who voted for approval. “I think the fact that the drug has retained activity against several evolving strains of the virus is also reassuring and gives hope that it will continue to do so in the future.”
However, the advisers expressed their concern for security. According to the FDA, more than 50% of patients eligible for Paxlovid may be taking a drug with a drug interaction at the time of diagnosis.
“I would just emphasize that we underscore the importance of risk mitigation for the prescribing primary care physician and other physicians in terms of drug interactions,” said David Hardy, MD, of the University of Southern California Keck School of Medicine, who voted for approval. “That’s where I think we may have problems — or I can tell where they may have problems — by prescribing this drug without a good understanding of what ritonavir does with other drugs.”
The FDA has said that these adverse reactions can be managed by stopping the drug, adjusting the dose, or increasing monitoring.
The drug is not yet approved. The FDA, which generally follows the committee’s recommendations, is expected to complete its review to approve Paxlovid in May.
More than 8 million people in the United States have received Paxlovid, a combination of the drugs nirmatrelvir and ritonavir, since it became available under emergency use authorization in December 2021.
