FDA Approves Paxlovid (nirmatrelvir tablets and ritonavir tablets) for Adult Patients at High Risk of
Progression to Severe COVID-19
Pfizer Inc. announced that the U.S. Food and Drug Administration approved Paxlovid™ (nirmatrelvir tablets and ritonavir tablets) 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. Paxlovid has been available in the U.S. since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk profile and indication for use in eligible adults remain consistent with the EUA. More than 11.6 million treatment courses of Paxlovid have been prescribed in the U.S. to date.
Based on the relative risk reduction seen across both clinical and real-world data, the FDA provided an estimate in March 2023 that more than 1,500 lives could be saved, and 13,000 hospitalizations avoided each week with Paxlovid use in eligible patients. At this time, the U.S. government will continue to oversee the distribution of Paxlovid, and U.S. residents eligible for Paxlovid will continue to receive the medicine at no charge.*
Paxlovid remains available for eligible children, 12 to 17 years of age (and weighing at least 40 kg), under the existing EUA. Pfizer continues to gather pediatric data from the ongoing clinical trial, EPIC-Peds (Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients) and intends to submit a supplemental New Drug Application (sNDA) to support the FDA approval of Paxlovid in children at a future date.
Paxlovid is currently approved or authorized for conditional or emergency use in more than 70 countries across the globe to treat COVID-19 patients who are at increased risk for progressing to severe illness. Paxlovid is now supplied in two different dose packs, one for standard dosing and one for moderate renal impairment dosing.
