Paxlovid Gets Advisory Panel Support for Full FDA Approval

The FDA’S Antimicrobial Drugs Advisory Committee (ADAC) voted 16 to 1 on Thursday in favor of Pfizer’s antiviral Paxlovid (nirmatrelvir and ritonavir) 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.

The expert panel was overwhelmingly supportive of the FDA granting traditional approval to a five-day course of Paxlovid in adults. If the agency agrees, Paxlovid could soon become the first oral approved treatment for mild-to-moderate COVID-19.

“Besides oxygen, Paxlovid has been the single most important treatment tool in this epidemic,” and it continues to be pivotal for those who are unvaccinated, elderly, and/or immunocompromised,” said Richard Murphy, chief of infectious diseases at the Veterans Affairs White River Junction Medical Center in White River Junction, Vt.

Paxlovid, which renders SARS-CoV-2 incapable of replicating, got emergency use authorization (EUA) on Dec. 22, 2021, for patients who are at high risk for progression to severe COVID-19.