It has been just revealed that the FDA made a terrible move and has just approved Remdesivir for treating covid-19. This is mind-blowing, as the results have been showing renal failure. Check out the following reports below.
FDA approved Remdesivir
On July 14, the U.S. Food and Drug Administration (FDA) approved Veklury (also known as remdesivir) to treat COVID-19 in people with severe renal impairment, including dialysis. However, it is important to note that there is data showing that the drug can increase the risk of kidney failure.
Remdesivir is an antiviral medication that targets the RNA in viruses to prevent replication. The FDA initially authorized its emergency use in May 2020 to treat people with severe covid-19, and it has since been approved for both adults and children as young as 28 days old who weigh at least 6.6 pounds. It is the first and only FDA-approved antiviral COVID-19 treatment for people with renal disease.
Use of Veklury to treat covid-19 symptomatology
The use of Veklury to treat covid-19 in people with severe renal impairment has been approved in the U.S. following the decision of the European Commission on June 26. The prescribing information for remdesivir has been updated to remove the need for adjusting the dose for patients with kidney problems. Additionally, the requirement for estimated glomerular filtration rate testing has been eliminated, which is a reliable method for measuring kidney function before administering 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 press release.
The company claims that the FDA approved the use of remdesivir in patients with severe renal impairment after analyzing the results of a phase 1 study and a phase 3 trial.
The phase 3 trial was randomized, double-blind, placebo-controlled, parallel-group, and multicenter, and focused on studying the drug’s interaction with the body and its safety profile. However, the study was terminated prematurely due to issues with feasibility and lower-than-expected enrollment, which made it difficult to assess the drug’s efficacy.
We suggest that you check out the latest reports about the matter in the original article posted by the online publication The Epoch Times.
