Originally published by our sister publication Infectious Disease Special Edition
The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted 16-1 that available data support the safety and effectiveness of nirmatrelvir+ritonavir tablets (Paxlovid, Pfizer) to treat mild to moderate COVID-19 in adults who are at high risk for progression to severe illness.
The Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in May.
The AMDAC based its vote on the