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Business & Technology

After Remdesivir Was Used to Treat COVID-19 for Months, It Receives FDA Approval

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After Remdesivir Was Used to Treat COVID-19 for Months, It Receives FDA Approval

2020-10-23 18:12:49

By Laura Tucker, Staff writer; Image: Intravenous drugs (Image source: Public domain)

While at first the news sounded promising, that the first official treatment for the coronavirus has been approved. But looking into the news more fully, it won't change much, as this Remdesivir has been in play since May, and the only reason it took this long to be approved seems to be that not all experts are really sold on it.

It also brings up a question of whether one of the reasons it's being approved is because it was one of the drugs Donald Trump was given when he was in the hospital after testing positive for COVID-19. He received a cocktail of experimental and existing drugs, and Remdesivir was one of them.

 The drug manufacturer, Gilead Sciences, announced on Thursday that the U.S. Food and Drug Administration had approved Remdesivir for the treatment of coronavirus infection.

No other drugs have been approved yet. Some had received emergency approval, which is what Remdesivir previously received, as did hydroxychloroquine. Despite Donald Trump touting the latter, it was pulled from use as an emergency treatment once unofficial studies showed it could hasten death.

Most likely because nothing else is available, Remdesivir, under the brand name of Veklury, was approved, even though it has only shown modest benefits.

"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," said Gilead Sciences 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."

The World Health Organization, of which the U.S. is no longer affiliated, after Trump pulled the country out, sponsored a global study that earlier this month found that Remdesivir did not help patients survive or even recover faster. However, a U.S. study found it shortened recovery time for some patients by about a third.

The FDA uses data submitted by a drug's maker when it is considering a drug for approval. Gilead submitted a study that was published in the New England Journal of Medicine. The study showed that Remdesivir shortened the length of the illness from about 15 days to about 11 among patients who are hospitalized.

Two other studies were considered by the FDA. One showed a slight benefit with the use of Remdesivir, while the other showed it didn't make much difference.

The former director of the Biomedical Advanced Research and Development Authority (BARDA), Rick Bright, expressed that he wasn't very impressed by Remdesivir.

"It's important to note that even the data that we saw in the United States from that drug show that the benefit was modest," Bright told Wolf Blitzer of CNN.

"It wasn't a home run. It wasn't a remarkable improvement in terms of mortality, or even the lengthening or shortening of the length of a hospital stay, but it did show some marginal benefit," he reported.

FDA Commissioner Dr. Stephen Hahn supported the approval by saying it's "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 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 risk,"  concluded Hahn. 

Politically, it's important for Trump to have this drug approved before the election. Despite his promises that a vaccine will be available very soon, experts still see it as not being available to the masses until next year.

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