Joe Raedle
The U.S. Food and Drug Administration (FDA) has convened a group of independent experts for a meeting on Mar. 16 to decide on the full approval for Pfizer’s (NYSE:PFE) COVID-19 pill Paxlovid.
The decision comes more than seven months after the company announced the U.S. regulatory submissions for its New Drug Application (NDA) for Paxlovid, which the FDA cleared in 2021 for emergency use for the treatment of mild-to-moderate COVID-19.
At the virtual meeting, the FDA’s drugs advisory committee on antimicrobial treatments will discuss the approvability of Pfizer’s (PFE) NDA, targeted at those aged 12 years and above who are at risk of developing severe COVID-19.
The FDA’s advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision.
The NDA is backed by data from the company’s Phase 2/3 EPIC-HR and EPIC-SR clinical trials, which indicated an 84% reduction in hospitalizations or death in people who received Paxlovid regardless of vaccination status within five days of symptom onset.
Read: As Pfizer (PFE) transitions the antiviral to a commercial market from government-led purchases, Seeking Alpha contributor SM Investor urges investors not to underestimate Paxlovid revenue.
