The U.S. Food and Drug Administration's Antimicrobial Drugs Advisory Committee voted in favor of recommending a full approval for Pfizer Inc's (PFE) COVID-19 pill Paxlovid in adults at high risk of progression to severe disease, the company said in a statement.
The company noted that the Committee voted 16 to 1 that available data support the safety and effectiveness of Paxlovid (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness.
The Committee's vote, while not binding, will be considered by the FDA when making its decision regarding the potential approval of Paxlovid.
If approved by the FDA, Paxlovid could be the first U.S. FDA-approved oral treatment for COVID-19. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is May 2023, the company said.
Under the FDA emergency use authorization, Paxlovid is currently authorized for use in, and remains available to, adults and pediatric patients at high risk of progression to severe COVID-19.
Pfizer said it continues to gather pediatric data from the ongoing clinical trial EPIC-Peds and intends to submit a supplemental New Drug Application 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.
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