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FDA Gives Shocking Approval For Remdesivir


The U.S. Food and Drug Administration (FDA) approved this month remdesivir, nicknamed ‘Run Death Is Near,’ to treat COVID-19 for individuals “with severe renal impairment, including dialysis,” according to a report by The Epoch Times. 

The FDA approved the toxic drug despite data showing it causes kidney failure.

Remdesivir was part of the standard COVID-19 treatment protocol in hospitals across the United States.

Many people lost loved ones at the height of the COVID-19 plandemic because of the administration of this multi-organ killer.

Yet, the corrupt regulatory agency approves the drug for kidney patients.

“My husband was given Remdesivir in the hospital, it shut down his kidney and put him into cardia[c] arrest. Remdesivir is now being used on kidney patients, that’s a death sentence,” Dawn Michael wrote.

Dr. Peter McCullough joined Grant Stinchfield on Real America’s Voice to discuss the FDA’s vile remdesivir approval.

Watch via Rumble:

The Epoch Times reports:

Remdesivir is an antiviral medication that targets the RNA in viruses to prevent replication. The FDA first authorized remdesivir for emergency use in May 2020 to treat people with severe COVID-19. It has since been approved for adults and children as young as 28 days who weigh at least 6.6 pounds.

Remdesivir is the first and only FDA-approved antiviral COVID-19 treatment for people with renal disease.

The U.S. approval follows the European Commission’s decision on June 26 to extend the approved use of Veklury to treat COVID-19 in people with severe renal impairment. The updated prescribing information for remdesivir doesn’t require adjusting the dose for renal-impaired patients and also removes the requirement that patients undergo estimated glomerular filtration rate testing—the most reliable way to measure how well the kidneys are working before taking the drug.

“The approval by the FDA of Veklury for the treatment of patients with renal impairment reflects the urgency to make this medicine available to these patients, and underscores the established safety profile for Veklury,” Anu Osinusi, vice president of Clinical Research for Hepatitis, Respiratory, and Emerging Viruses at Gilead Sciences, said in a statement.

According to the company, the FDA based its approval of remdesivir for use in patients with severe renal impairment on the results of a phase 1 study and a phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study trial that assessed how the drug interacts with the body and its safety profile. Yet the phase 3 study was terminated prematurely because of “feasibility issues” and because it was “underpowered to assess for efficacy because of lower-than-expected enrollment.”

“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,” McCullough wrote in Courageous Discourse.

From Courageous Discourse:

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.



 

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