On Thursday, The Food and Drug Administration announced that they had formally approved remdesivir as the first drug to treat Covid-19, a drug in which the government is confident about its safety and effectiveness for hospitalized patients.
The F.D.A. has approved the drug for adults and pediatric patients 12 years of age and older and weighing at least 88 pounds who require hospitalization for Covid-19.
In May, the F.D.A. granted remdesivir emergency authorization after a trial by the National Institutes of Health found that it modestly reduced the recovery time in hospitalized patients. Donald Trump received the same antiviral drug after he had begun to show symptoms earlier this month. It should be noted that remdesivir does not prevent death from Covid-19.
The drug was officially approved by the F.D.A when remdesivir had cleared meticulous regulatory hurdles that involved a more thorough review of the clinical data and manufacturing quality since it was given the authorization in May.
In a statement the agency’s commissioner, Dr. Stephen M Hahn said, “The FDA is committed to expediting the development and availability of Covid-19 treatments during this unprecedented public health emergency.” He said, “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.”
Remdesivir, which was originally created to treat Ebola and hepatitis C, interferes with the reproduction of viruses by jamming itself into new viral genes. The World Health Organization sponsored a study of more than 11,000 people in 30 countries, they found that the drug failed to prevent deaths in patients with Covid-19. The drug did not go through an outside panel of experts, called an advisory committee, before being approved.
Dr. Peter Lurie, president of the Center for Science in the Public Interest said, “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.” She added, “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.”
“As part of the FDA’s Coronavirus Treatment Acceleration Program, 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. Hahn said.
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