Remdesivir Is the First FDA-Approved Treatment for COVID-19

Andrew Cummings
October 24, 2020

Remdesivir, an antiviral medication given intravenously, is now approved for anyone hospitalized with COVID-19.

Mexico will not necessarily follow the U.S. Food and Drug Administration (FDA) in approving Gilead Science Inc's antiviral drug remdesivir for use in COVID-19 patients, a top Mexican health official said on Friday. Based on the strength of these data, remdesivir has become a standard of care for the treatment of COVID-19 in hospitalized patients.

In addition to the FDA's approval, a revised EUA has been issued for the use of remdesivir to treat hospitalized pediatric patients under age 12 years and weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to less than 40 kg with suspected or laboratory confirmed COVID-19 for whom use of an intravenous agent is clinically appropriate. The drug has also been granted authorization for emergency use in some countries, including Japan. Previously, the intravenous drug was exclusively available under an emergency use authorization (EUA) from the agency.

"The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency", Dr. Stephen Hahn, the agency's commissioner, said in a statement.

A second randomized, open-label multi-center clinical of hospitalized adult subjects with moderate COVID-19 compared treatment with Veklury for five days and treatment with Veklury for 10 days with standard of care. "Overall, the odds of clinical improvement at Day 15 were also statistically significantly higher in the Veklury group when compared to the placebo group", stated the release.

Its study involving more than 1,000 people, the results of which were released in April, found that patients on the drug had a 31 percent faster time to recovery than those on a placebo.

"This trial has just been put up (made public), their interim results have been put up on the website. This has not yet been peer reviewed, however, we find that these drugs are not performing as we had expected", Dr Balram Bhargava, Director General, Indian Council of Medical Research said on October 20, during a briefing on the actions taken by the government to tackle Covid-19.

"We believe our results are very robust", Swaminathan said.

Meanwhile, some Covid-19 doctors said they found the drug beneficial in cutting down treatment timelines in some cases. Analysts estimate that remdesivir will have sales of $2.17 billion this year, according to 13 surveyed by Bloomberg.

The FDA said that remdesivir is suitable for use on patients age 12 years and older.

Sales of remdesivir here have risen substantially - almost 96 per cent in July-September for the four aforementioned brands - PharmaTrac data showed.

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