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'Highly significant': Data on Gilead drug raises hopes in Covid-19 fight

US Food and Drug Administration said it has been in discussions with Gilead about making remdesivir available to patients as quickly as possible

Donald Trump
President Donald Trump speaks during a coronavirus task force briefing at the White House. Photo: PTI
Reuters
5 min read Last Updated : Apr 30 2020 | 12:58 PM IST
The top US infectious disease official said Gilead Sciences Inc’s experimental antiviral drug remdesivir will become the standard of care for COVID-19 after early clinical trial results on Wednesday showed it helped patients recover more quickly from the illness caused by the coronavirus.

Preliminary results from a US government trial showing that patients given remdesivir recovered 31% faster than those given a placebo, were hailed by Dr Anthony Fauci as “highly significant.” "This is really quite important," Fauci told reporters at the White House, likening it to a moment in 1986 "when we were struggling for drugs for HIV and we had nothing."

The US Food and Drug Administration said it has been in discussions with Gilead about making remdesivir available to patients as quickly as possible, but the agency declined to comment on any plans to grant the drug regulatory approval.

"I want them to go as quickly as they can," President Donald Trump said, when asked if he wanted the FDA to grant emergency use authorization for remdesivir. "We want everything to be safe, but we would like to see very quick approvals, especially with things that work."


The closely watched drug, given by intravenous infusion to hospitalized patients, has moved markets in the past few weeks following the release of data from several studies that painted a mixed picture of its effectiveness, and Fauci cautioned that the latest data still needs to be analyzed.

Gilead's shares rose more than 5% on Wednesday to close at $83.14 and are up 27% so far this year.

Interest in remdesivir has been high as there are no approved treatments or preventive vaccines for Covid-19, and doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in severe cases.

Gilead earlier this month said it was prepared to donate to hospitals its existing supply of 1.5 million doses of remdesivir, which it said was enough for more than 140,000 patients, although that number would increase if the drug could be given for a shorter duration. Regulatory approval of the drug would clear the way for commercial sales.


"We are working to build a global consortium of pharmaceutical and chemical manufacturers to expand global capacity and production," Gilead Chief Executive Daniel O'Day said in an open letter on Wednesday.

He also said Gilead is looking at ways to potentially bring the treatment to a broader patient population by investigating other formulations and means of delivery.

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, said partial results from its 1,063-patient trial show that hospitalized COVID-19 patients given remdesivir recovered in 11 days, compared to 15 days for patients given a placebo. The study showed a trend toward better survival for remdesivir - 8% of patients given the drug died compared with 11.6% in the placebo group.

The trial's lead researcher told Reuters on Friday that full results could come by mid-May.

"The full dataset will provide more clarity on how remdesivir can best be used," said Dr. Aneesh Mehta, a researcher on the NIH trial from Emory University School of Medicine in Atlanta.


Fed cautions

The head of the Federal Reserve, Jerome Powell, on Wednesday dashed lingering hopes for a fast rebound from the coronavirus pandemic, saying the US economy could feel the weight of consumer fear and social distancing for a year or more in a prolonged climb from a deepening hole.

After a two-day policy meeting in which the US central bank kept interest rates near zero and promised to expand emergency programs as needed to help the battered economy. Powell offered no sanguine words about how fast the country might return - if ever - to the near-record low unemployment and solid growth of just a few weeks ago. However, he said, "The first phase of recovery may actually happen soon."

In a matter of weeks, the US has gone from historically low unemployment to seeing more than 26 million people file for unemployment benefits and the sharpest plunge in activity since the 2007-2009 Great Recession, as authorities across the country shut down large swaths of industry and commerce to slow the spread of the novel coronavirus.

Gross domestic product declined at a 4.8% annualized rate in the first quarter, ending the longest expansion in U.S. history, the Commerce Department reported.

'WHO: A pipe organ for China'

President Donald Trump termed the World Health Organization as "a pipe organ for China" and said the United States will soon come out with its recommendations on the global body, followed by one on Beijing. 

Trump has launched an investigation into the WHO's role in the spread of coronavirus and have accused it of siding with China during the pandemic. Pending an investigation, the President has stopped US aid to the WHO. The investigation would look into the role of China and as to how coronavirus spread from its Wuhan city.

"What are you hoping to learn about China and the World Health Organization with this investigation you have commissioned with the intelligence agencies?" he was asked.

"It is coming in and I am getting pieces of information already and we are not happy about it. We are by far the largest contributor to WHO,...and they misled us. I don't know... We knew things that they didn't know and either they didn't know it or they didn't tell us or you know right now they are literally a pipe organ for China. That is the way I view it," Trump said.


Topics :CoronavirusLockdownUnited StatesDonald Trump

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