FDA Approves Remdesivir in Kidney Patients after Failed Trial
Action added to Long List of Pandemic Regulatory Malfeasance
By Peter A. McCullough, MD, MPH
In a move that defies all regulatory convention, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury® (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. With this approval, Veklury is now the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease but has no efficacy data to support its administration.
The phase 3 REDPINE trial failed to recruit sufficient subjects to assess efficacy. Instead of properly rejecting the application, the FDA went ahead and approved the drug with insufficient safety and efficacy data. The drug has struggled in recent years as patients commonly decline the antiviral since the November, 2020, WHO warning against inpatient use. Remdesivir can cause both kidney injury and liver damage, thus with no mortality benefit, many believe it should not be used.
The FDA approval action defies logic and will be added to a long list of acts that will be considered malfeasance and will be up for review when the commissioner and agency is finally called to justice.
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