Korea approves emergency use of Gilead's anti-viral drug to treat COVID-19

Korea approves emergency use of Gilead's anti-viral drug to treat COVID-19

Remdesivir is now approved for emergency use authorization by the FDA to treat hospitalized patients with severe COVID-19.

Two ampules of Ebola drug Remdesivir are pictured during a news conference at the University Hospital Eppendorf (UKE) in Hamburg, Germany, April 8, 2020, as the spread of coronavirus disease (COVID-19) continues.

On Monday, Gilead Sciences had reported Phase 3 SIMPLE trial results that found that hospitalised Covid-19 patients on the drug were 65 percent more likely to see clinical improvement by the eleventh day compared with those who were not on the drug.

At Day 11, a higher proportion of patients in the 5-day treatment group achieved improvement in clinical status versus the standard of care group, Gilead said.

Jefferies equity analyst Michael J. Yee, the JPMorgan biotechnology research team, and the Barclays health care team have all raised doubts over the ability of remdesivir to become the go-to treatment against the virus.

The company-led study involved almost 600 patients who had moderate pneumonia but did not need oxygen support. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.

Remdesivir is presently approved in Japan as a treatment for patients with COVID-19.

Gilead Sciences had reported that the drug has shown modest benefit in patients with moderate symptoms given a five-day regimen.

The drug was granted emergency use authorisation by the US Food and Drug Administration last month and has received approval by Japanese health regulators.

The emergency approval followed early results from a large, placebo-controlled study run by the USA government that showed patients getting remdesivir recovered faster than those who got a placebo.

Gilead's shares have rallied 15.7% in the year so far compared with the industry's growth of 9.1%.

The estimate comes a month after Boston-based Institute for Clinical and Economic Review suggested a price of $4,500 per US treatment course for 10 days. Nausea and headache were a little more common among those on the drug. This open-label clinical trial assessed 5-day and 10-day treatment courses of the remdesivir plus standard of care against the standard of care alone.

"The drug, which is administered in the form of an injection, has been approved to be sold by retail on the prescription of specialists for use in hospital or institutional setup only", another source told PTI.

As for the second reason, it cited other countries such as the US, Japan and the United Kingdom which are allowing the use of remdesivir to treat COVID-19.

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