Gilead’s Veklury Approval Shows US FDA’s Existing Regulatory Tools Are Up To The COVID-19 Challenge
The FDA emphasized the rigor of its review of the first COVID-19 therapy, which used few expedited pathways on its way to approval after a two-and-a-half-month review. Post-marketing studies will address remaining concerns about dosing and special populations.
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The agency’s quickest approvals include two in 2020 – Gilead’s Veklury and Seattle Genetics’ Tukysa – but two 1990s AIDS drugs are at the top of the list.
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Gilead says remdesivir improved mortality and clinical recovery in COVID-19 patients, but the findings come from a retrospective analysis, not a traditional clinical trial.