Pfizer says continues to gather pediatric data on Paxlovid

If approved by the FDA, "Paxlovid could be the first U.S. FDA-approved oral treatment for COVID-19," Pfizer said. The target Prescription Drug User Fee Act, or PDUFA, action date for a decision by the FDA is May 2023. Under the FDA emergency use authorization, or EUA, Paxlovid is currently authorized for use in, and remains available to, adults and pediatric patients 12 years of age and older weighing at least 40 kg at high risk of progression to severe COVID-19. "Pfizer continues to gather pediatric data from the ongoing clinical trial EPIC-Peds and intends to submit a supplemental New Drug Application, or NDA, to support the FDA approval of Paxlovid in children at a future date. In February 2023, the European Commission granted standard Marketing Authorization of Paxlovid for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe, Pfizer said.