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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Pandemic Perspectives: US FDA ACTT’s On Its Faith In Randomized Trials With Veklury Approval Despite WHO Study
US FDA has not deviated from its bedrock trust in the value of ‘statistically reliable’ endpoints amidst the COVID-19 pandemic, the Pink Sheet’s Drug Review Profile of Gilead’s Veklury shows.
Since the WHO’s pandemic declaration, the agency has granted 10 EUAs for therapeutics and three for vaccines, all of which were reviewed in less than 90 days; EUA requests from government entities boast two of the three fastest review times but were revoked or limited in the face of emerging evidence.
Although compounding of certain shortage drugs is allowed during the public health emergency, remdesivir is off limits due to its complexity. Providers should only use the FDA-approved version of the drug, Gilead’s Veklury, the agency says.