U.S. FDA approves Gilead's remdesivir for COVID-19 treatment

FDA approves first COVID-19 drug the antiviral remdesivir

Gilead Sciences's antiviral Veklury, better known as Remdesivir, was given the stamp of the approval by the country's health watchdog overnight for use as a treatment against Covid-19. Last week, a large study led by the World Health Organization found the drug did not help hospitalized COVID-19 patients, but that study did not include a placebo group and was less rigorous than previous ones that found a benefit.

The drug is called Veklury- and it's a remdesivir antiviral that allegedly cuts recovery time from 15 days to an average of 10.

The FDA also issued a new emergency use authorisation on Thursday for remdesivir to treat hospitalised paediatric patients under age 12 who weigh enough to receive an intravenous drug.

And US President "Donald Trump" received the drug "Remdisiver" during his diagnosis of HIV, among a group of other treatments, before the test results turned negative.

"This 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", said Stephen M Hahn, Commissioner, FDA.

The WHO, however, has previously stated that remdesivir is largely ineffective when used as a treatment against COVID-19, per BBC.

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"It's not really a treatment in the sense that it'll cure people", Dr. Irwin Redlener, director of the Pandemic Resource and Response Initiative at Columbia University's National Center for Disaster Preparedness, said earlier this month on MSNBC, NBC News reported.

The decision was taken after carefully analyzing three different "randomized, controlled" clinical trials. The journal also pointed out that the drug was found to reduce the progression of the illness among severely ill patients who require oxygen therapy as part of their treatment.

Earlier, the physician stated that in some regions of Ukraine in clinics the same is observed collapse due to COVID-19, as in its time in Italy. In the overall patient population, there was a trend toward reduced mortality with remdesivir compared with placebo at day 29 (11.4% vs. 15.2%, HR 0.73; 95% CI, 0.52 to 1.03).

Remdesivir has become the standard of care for patients hospitalized with severe COVID-19 even though it has not been shown to improve survival. The amount that patients pay out of pocket depends on insurance, income and other factors.

There is one notable caveat to the FDA's move, however.

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