Remdesivir Becomes 1st FDA-Approved COVID-19 Treatment in the US

Remdesivir is approved despite the World Health Organization’s solidarity trials showing the drug doesn’t work.

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Remdesivir, the drug by Gilead Sciences, became the first US Food and Drug Administration-approved drug for treating COVID-19, despite the World Health Organization's solidarity trials showing that the drug doesn't work.

It will be sold under the brand name Veklury. So far, the drug was being used by doctors in the US under emergency-use authorisation.

In India, off-label use of remdesivir is permitted under Union Health Ministry's clinical guidelines to treat COVID-19.

Gilead Sciences, in a statement, said:

“In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalisation. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.”

Results from WHO's Solidarity Trials Showed the Drug Doesn't Work

On 15th October, the World Health Organization released the results from their Solidarity Therapeutics Trial and found that Gilead Sciences Inc’s Remdesivir had either no or very little effect on COVID-19 patient’s chances of survival or length of hospital stay.

As per trial data, of the 2,743 patients on remdesivir, 301 died and of the 2,708 patients on usual care, 303 died.

FIT spoke to intensivist Dr Sumit Ray, a senior consultant of Critical Care Medicine at Holy Family Hospital in Delhi, who runs a COVID ward, on how it would impact physicians treating COVID patients.

“There was an article that said Remdesivir is a drug in search of a disease. It failed in Ebola, it failed in SARS and MERS. So we were skeptical.”

Remdesivir: What is It?

Remdesivir is an antiviral drug developed by American pharmaceutical giant Gilead Sciences. It was made to treat hepatitis C and respiratory syncytial viruses over a decade ago, but it never got marketing approval.

Antivirals are drugs used for treating viral infections.

COVID-19 brought the drug back into the picture – and US President Trump offered Remdesivir to UK Prime Minister Boris Johnson, despite no clinical evidence that it worked for COVID-19.

Gilead, too, did not claim it worked, but it became thrust into the limelight as a potentially promising drug. Soon in April, the New England Journal of Medicine published a study where out of 61 patients who were hospitalised with COVID-19, 53 were given the drug and 68 percent improved while 13 percent died. However, they were not able to say this was due to the drug as there was no control group. It is important to note that Gilead employees co-authored the paper. “This presents a huge conflict of interest,” says Dr Ray.

FDA used the above study as one of the examples of why the drug works.

In a quote on CNN, FDA Commissioner Dr Stephen Hahn, 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."

In India, the Indian Council of Medical Research (ICMR) has said that they are reviewing the data from WHO's solidarity trials. As of today, remdesivir remains a part of the clinical guidelines.

(The story was first published on Quint FIT.)