Monday, May 20, 2024

FDA approves Remdesivir as Corona drug; Not good enough though to prevent deaths

The Food and Drug Administration (FDA) approved Remdesivir drug for treating Covid-19, making it the first and only drug so far to have received federal approval for the coronavirus.

Remdesivir, an antiviral medication given intravenously, had already been authorized for use on an emergency basis since May after a trial by the National Institutes of Health but it has received full FDA approval after drugmaker, Gilead Sciences, submitted additional evidence to support their safety claims.

The FDA has approved the drug for the adult over age 12 who require hospitalization for Covid-19. The United States President, Donald Trump, also received the same antiviral drug after he began showing symptoms of Corona earlier this month.

Remdesivir, which was originally developed as a treatment for Ebola and Hepatitis C, works by blocking the virus’s ability to make more copies of itself.

However, a study of more than 11,000 people in 30 countries sponsored by the World Health Organization (WHO) found that the drug failed to prevent deaths in patients with Covid-19.

Dr. Peter Lurie, a former associate commissioner with the FDA also said that the drug did not go through an outside panel of the expert before being approved.

“The F.D.A. tends to pick for advisory committees those drugs that are most novel and those that present safety issues, and those that are close calls with respect to effectiveness,” Dr. Lurie said. “This is not a blockbuster drug. This is not a massive breakthrough. It’s a drug that appears convincingly to benefit patients, but it’s not some kind of miracle cure.”

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