Pfizer gets PAXLOVID FDA approval for COVID-19 in high-risk adults

Pfizer has obtained approval for PAXLOVID, an oral combination therapy of nirmatrelvir tablets and ritonavir tablets, from the US Food and Drug Administration (FDA) to treat adult patients with mild-to-moderate COVID-19 who are at a high risk of hospitalization or death.

PAXLOVID has been available in the US since December 2021 under Emergency Use Authorization (EUA), and its overall benefit-to-risk profile and approved indications for eligible adults remain consistent with the EUA. This therapy acts as a SARS-CoV-2 main protease (Mpro) inhibitor, targeting the virus’ 3CL protease.

PAXLOVID FDA approval is supported by scientific evidence provided by Pfizer, including safety and efficacy data from the EPIC (Evaluation of Protease Inhibition for COVID-19) clinical development program.

The phase 2/3 EPIC-HR study, which included unvaccinated, non-hospitalized adults aged 18 and above with confirmed COVID-19 and an elevated risk of severe disease progression, demonstrated an 86% reduction in the risk of COVID-19-related hospitalization or death within 28 days for patients who initiated PAXLOVID treatment within five days of symptom onset, compared to placebo.

Additionally, PAXLOVID FDA approval was further reinforced by results from a secondary endpoint of the Phase 2/3 EPIC-SR study, indicating a numerical reduction in COVID-19-related hospitalizations or death within 28 days for a subgroup of non-hospitalized adults aged 18 and above with confirmed COVID-19, at least one risk factor for severe disease progression, and full vaccination.

Albert Bourla — Pfizer chairman and CEO, commenting on PAXLOVID FDA approval, said: “Great advancements have been made in the fight against COVID-19, yet the virus remains a present and unpredictable concern. This is especially true for the hundreds of millions of American adults who are age 50 or older or are otherwise at high risk for progression to severe illness, even if symptoms are initially mild.

“Today marks a monumental milestone as PAXLOVID became the first COVID-19 oral treatment to be approved by the U.S. FDA, underscoring the value it brings to patients, providers, and health systems alike.”

Presently, PAXLOVID is either approved or authorized for conditional or emergency use in over 70 countries to treat COVID-19 patients at an increased risk of severe illness.