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FDA gives go ahead to Gilead’s Remdesivir for emergency use to treat critical corona patients




On Friday, the US Food and Drug Administration gave a go ahead to medical community to use Remdesivir, a drug by Gilead. The drug proved to be effective in speedy recovery of the novel coronavirus patients it was tested on. The FDA clarified that the intravenous drug could be used only if a patient was in critical condition such as unable to breathe without oxygen supplement or ventilator.

The FDA’s approval came quick, in a record time, which otherwise takes months including patient work, but due to the ongoing global health emergency, the experimental drug received green signal in no time. The US regulator’s decision was based on the government-sponsored research which highlighted that Remdesivir increased the recovery rate of Covid-19 patients by 31% i.e. about 4 days on an average.

The US President Donald Trump announced the FDA’s decision at the White House briefing alongside Gilead CEO Daniel O’Day and Food and Drug Administration Commissioner Stephen Hahn.“We want to thank the collaborators that brought remdesivir to this point and many of our people that have been part of this, in fact, the caregivers,” O’Day told reporters. Gilead said that it would donateall the available stock of remdesivir (i.e 1.5 million vials) and would also increase its production to deliver throughout the country.

“This was lightning speed in terms of getting something approved” said Hahn, calling the drug “an important clinical advance.” FDA’s approval came few days after Dr Anthony Fauci spoke about Remdesivir. He said, “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery. … What it has proven is that a drug can block this virus.”

Besides the initial go ahead for case by case use, the Gilead Sciences’ pathbreaking drug is yet to receive full approval from FDA, which is an extensive process and would require more research. The US regulator acknowledged that “there is limited information known about the safety and effectiveness of using Remdesivir”.

Dr. Sameer Khanijo, a critical care specialist, told the Associated Press that he would want to see more results before popularising the drug’s benefits.
“I don’t think this is a cure yet, but I think it’s starting to point us in the right direction,” said Khanijo of North Shore University Hospital in New York. “As a society it’s nice to have something that will help stem the tide of this disease.”

“This is a very, very early stage so you wouldn’t expect to have any sort of full approval at this point,” said Cathy Burgess, an attorney specializing in FDA issues. “But obviously they want to get this out to patients as quickly as possible.”

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