Ahead of adcomm for full approval, FDA estimates Pfizer's Covid pill could save 1,500 lives per week
Ahead of Thursday’s meeting of the FDA’s Antimicrobial Drugs Advisory Committee, which will decide whether to flip Pfizer’s blockbuster Covid-19 pill from an EUA to a full approval, the agency released a generally positive recommendation but noted the significant risks from drug-drug interactions.
While noting an absolute risk reduction with Paxlovid for the hospitalization/death endpoint of about 1% to 2% for a patient with baseline SARS-CoV-2 immunity, on the population level, FDA says there “remains a large benefit.” The agency also notes that Pfizer’s pivotal clinical trial results support the efficacy of Paxlovid for treating mild-to-moderate Covid in high-risk adults regardless of vaccination status or prior infection.
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