The US Food and Drug Administration (FDA) on October 22 approved Gilead Sciences Inc’s antiviral drug Remdesivir for treating patients hospitalised with COVID-19, making it the first and only drug approved for the disease in the United States.
“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.”
The Remdesivir approval is based on a U.S. government-sponsored trial involving more than 1,000 hospitalized coronavirus patients that found that those who received the drug recovered about five days faster than those who got a placebo.
The overall side-effect rate of Remdesivir was similar to the placebo in the government study. The most common side effects are nausea and elevated liver enzymes, according to the product’s label.
On 15th October, the World Health Organisation 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 2743 patients on remdesivir, 301 died and of the 2708 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.
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 per cent improved while 13 per cent died.
However, they were not able to say Remdesivir 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.
