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The US Food and Drug Administration Agency has approved Remdesivir for the treatment of coronavirus infection.
Remdesivir, sold under the brand name Veklury, is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. It is administered via injection into the vein.
Gilead Sciences, the maker of the drug, disclosed the approval of the drug by the US in an announcement, yesterday, stating that the drug has become the first to be approved for the treatment of COVID-19.
“In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40kg) for the treatment of COVID-19 requiring hospitalization,” the company said in a statement.
“Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.”
A World Health Organization (WHO) sponsored global study earlier this month, found that Remdesivir did not help patients survive or even recover faster, but a US study found that the infused drug shortened recovery time for some patients by about a third.
The FDA when considering approval often use data submitted by a drug maker. Gilead Sciences submitted a study published in the New England Journal of Medicine that showed the drug shortened the course of illness from an average of 15 days to about 11days in hospitalized patients.
The FDA also considered two other studies, one which showed a slight benefit of the drug and another showed the drug did not make much difference.
In the words of FDA Commissioner, Dr Stephen Hahn, “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.”
“As part of the FDA’s Coronavirus Treatment Acceleration Programme, the agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks”, Dr Stephen concluded.
Hanoky Media has gathered that Remdesivir, which is a broad-spectrum antiviral medication, is usually administrative via injection into the vein, and has been authorized for emergency use in India, Singapore, the United Kingdom, Japan, the European Union, Australia, and now in the United States for people with severe symptoms.
However, It has been reported that the most common side effect in healthy volunteers is a rise in blood levels of liver enzymes (a sign of a liver problem), while the most common side effect in people with COVID-19 is nausea.
Remdesivir was originally developed to treat hepatitis C and was then tested against Ebola virus disease and Marburg virus disease, but was ineffective for all of these viral infections.