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Home » FDA Requests More Trial Data Related to Pfizer’s Paxlovid
FDA Requests More Trial Data Related to Pfizer’s Paxlovid
August 24, 2022
The FDA has asked Pfizer for additional trial data to address concerns about the return of COVID-19 symptoms within days of an initial treatment with the company’s combination antiviral drug Paxlovid (nirmatrelvir, ritonavir).
The agency wants the company to conduct a placebo-controlled trial to evaluate a subsequent treatment course of Paxlovid and expects to see topline results by Sept. 30, 2023.
Pfizer is also expected to submit data by the same deadline from a controlled trial to evaluate different durations of Paxlovid treatment in immunocompromised patients with mild-to-moderate COVID-19.
Paxlovid is currently FDA-authorized for treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older weighing at least 40 kg.
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