United States President Donald Trump on Friday issued an emergency approval for the use of remdesivir, an antiviral drug, as a treatment for patients severely ill with Covid-19, the disease caused by the coronavirus.
The Food and Drug Administration approved the use of the drug – designed to treat both hepatitis and a common respiratory virus – under emergency use provisions, after a clinical trial demonstrated some improvements among severely ill patients.
There are some reports on the drug, made by American biopharmaceutical company Gilead Sciences, being able to help Covid-19 patients.
“It is a really promising situation,” Trump said at the White House, according to AFP. He was also joined by Gilead’s CEO Daniel O’Day. “We are humbled with this first step for hospitalised patients,” said O’Day said. “We want to make sure nothing gets in the way of these patients getting the medicine.” The company has previously announced it was donating some 1.5 million doses for free.
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The use of the drug will be authorised for adults or children who are hospitalised with suspected or confirmed Covid-19 and those with a “severe” condition, meaning they have low blood oxygen levels, need oxygen therapy or are on a mechanical ventilator, the Food and Drug Administration said. Patients who receive the drug will be provided with a fact sheet, it added.
The National Institute of Allergy and Infectious Diseases-sponsored clinical trial of the drug included over 1,000 hospitalised patients and found that those receiving remdesivir recovered faster by 31%, or about four days on an average, than those who get a placebo.
Remdesivir, which is administered by an injection, was already available to some patients in intensive care who enrolled in clinical trials, or who sought it out on a “compassionate use” basis.
The approval for the use of the drug came days after Dr Anthony Fauci, the US government’s top infectious disease expert, expressed optimism about the results of a remdesivir drug trial.
“Although the results were clearly positive from a statistically significant standpoint, they were modest,” Fauci told NBC News on Thursday. “While it is not considered a miracle cure, remdesivir’s trial achieved a ‘proof of concept’, which could pave the way for better treatments.”
The number of coronavirus-related deaths in the United States rose by 1,883 on Saturday, taking the toll to 64,808. The total number of cases stand at 11.03 lakh, according to the Johns Hopkins tracker.
Meanwhile, globally, the coronavirus has infected 33.43 lakh people and killed at least 2.38 lakh people.