FDA adcomm votes in favor of Pfizer's Covid-19 pill Paxlovid
The FDA’s Antimicrobial Drugs Advisory Committee voted 16-1 that the benefits of Pfizer’s Covid-19 pill Paxlovid outweigh the risks in adults with mild-to-moderate illness.
The vote followed hours of discussion on topics ranging from efficacy in people who have already been vaccinated or infected to drug-drug interactions (DDIs). Pfizer submitted a request to convert its EUA to a full approval back in June, but the FDA extended its review period by three months to consider additional data submitted, the company announced in December. The current PDUFA action date for a decision by the FDA is May 2023.
Just one committee member voted against the question: “Is the overall benefit-risk assessment favorable for Paxlovid (nirmatrelvir and ritonavir tablets) when used for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death?”
While members who voted yes agreed that efficacy and safety have been demonstrated, they added that it’s important to understand who is at high-risk and who will benefit from the drug. They also echoed the need to keep an eye on DDIs, as well as ongoing and future studies by Pfizer on symptomatic rebound and the drug’s impact on immunosuppressed, pediatric and pregnant patients.
Patient representative Terry Gillespie, who voted no, said she has one lung and has had Covid four or five times. Gillespie said she was never offered Paxlovid by medical professionals and is “concerned about the doctors knowing actually when to prescribe it to somebody, say, like me.”
In comments on the strength of evidence for use of Paxlovid in patients who have already been vaccinated or previously infected, committee members said more data are needed.
“I would just agree with those that said the evidence isn’t as compelling as in those that are unvaccinated,” committee member Paige Waterman said. “I don’t think we’re ever going to have a fully vaccinated population, whatever fully vaccinated means, although taken together with prior infection I guess would give us decent numbers. I agree with the points made about individualize decisions. As we’re saying, physicians need to recognize indications. Who meets this criteria?”
If granted full approval, Paxlovid’s EUA will remain in place so that adolescents 12 years and older can continue to be treated with the drug. In the US, more than 10 million treatment courses of Paxlovid have been prescribed to date, according to Pfizer.
While the FDA does not need to follow an adcomm’s recommendations, it typically does. Pfizer has an ongoing trial for Paxlovid in children and plans to file a supplemental NDA for approval in children.