WHO Recommends Against Use of Gilead Covid-19 Drug Remdesivir -- Update

By Joseph Walker 

The World Health Organization said Thursday it recommends against the use of remdesivir, the antiviral drug for Covid-19 made by Gilead Sciences Inc., after concluding that there isn't evidence that the drug reduces deaths or recovery times.

The WHO said a panel of international experts that advise the agency on treatments based its recommendation on data from four international clinical trials comparing the effects of several drug treatments.

Remdesivir "has no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement," the WHO said.

Gilead said remdesivir is recognized as the standard of care for hospitalized Covid-19 patients by health organizations in the U.S., Japan, U.K. and Germany, based on multiple studies published in peer-reviewed journals.

"We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with Covid-19 in approximately 50 countries," Gilead said.

Gilead's remdesivir, sold under the brand name Veklury, was authorized for U.S. emergency use in May, and received full approval in October.

The U.S. approval was based primarily on data from a National Institutes of Health study showing hospitalized patients receiving remdesivir recovered five days faster than those receiving placebos. Among patients receiving remdesivir, 11% died, compared with 15% of placebo patients; the difference wasn't statistically significant.

In October, the WHO said in a press release that a study it had sponsored found that remdesivir had failed to show a benefit over standard treatment alone. WHO officials said at the time that the study results would be published in a peer-reviewed journal.

Gilead said the study wasn't as rigorously designed as other studies showing that remdesivir did provide a benefit.

The WHO said in its statement Thursday that further studies have to be done to prove that remdesivir does benefit patients. Given the drug's risk of side effects, high cost and labor required to administer the intravenous therapy, it considered the recommendation to be appropriate, the WHO said.

Write to Joseph Walker at [e-mail]

(END) Dow Jones Newswires

November 19, 2020 19:39 ET (00:39 GMT)

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