Paxlovid Receives FDA Approval for COVID-19

Paxlovid (nirmatrelvir tablets and ritonavir tablets), first authorized for emergency use in December 2021 for COVID-19, has received approval from the FDA for treatment of mild-to-moderate symptoms of the disease in adults who are at high risk for progression to severe COVID-19.

The oral treatment has been made available at no charge to patients since its market entry, and remains so at this time. The drug remains available for eligible children, aged 12-17 years, under the existing emergency use authorization.

Approval was based on efficacy data from the phase 2/3 study which showed an 86 percent reduction in risk of COVID-19-related hospitalization or death from any cause in patients who took PAXLOVID within five days of symptom onset.

The FDA provided an estimate in March that 1,500 lives and 13,000 hospitalizations could be avoided each week if Paxlovid were use in eligible patients, the company said.

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