Advocacy Group Petitions FDA to Consider Revoking Remdesivir Approval
Public Citizen is urging the FDA to convene an expert panel to discuss rescinding approval for Gilead Sciences’ Veklury (remdesivir) as a COVID-19 treatment.
The advocacy group argues that the agency made a mistake when it failed to refer Gilead Sciences’ New Drug Application for remdesivir to the FDA’s Antimicrobial Drugs Advisory Committee before granting the antiviral full approval on Oct. 22, 2020.
“The FDA’s previous failure to convene its own public advisory committee to consider whether to approve remdesivir was inexcusable,” said Michael Abrams, lead author of a letter sent by the group to Acting Commissioner Janet Woodcock and Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
“This failure is particularly troubling given that the agency was aware of evidence from a major clinical trial that raised substantial doubts about whether the drug provides clinically meaningful benefit,” Abrams said, referencing a World Health Organization study that found no evidence of the drug’s efficacy in treating COVID-19.