Gilead says remdesivir data shows encouraging results against coronavirus

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Gilead says remdesivir data shows encouraging results against coronavirus 1

Samuel Brown, director of pulmonary and critical care research at Intermountain Medical Center in Utah, also stressed the limits of the data announced Wednesday.

“I’m skeptical of releasing gossip before the topline results are available. All it does is stir up emotions without data to tether those emotions to reality,” he said. “And emotions untethered to reality are a serious problem during the pandemic.”

Gilead defended itself in a press statement. “Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic,” said Merdad Parsey, Gilead’s Chief Medical Officer. “Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug.”

The results from the NIAID trial are “a very important proof of concept,” agency chief Tony Fauci said during a meeting today in the Oval Office, according to a pool report. But the scientist urged caution in interpreting the data. “You’re going to hear more details about this this will be submitted to a peer reviewed journal, and will be peer reviewed appropriately,” he said.

President Donald Trump, who has repeatedly touted unproven coronavirus drugs at White House briefings, was more upbeat about the trial results. “It’s a very positive event,” he said, according to the pool report.

Former FDA Commissioner Scott Gottlieb said Gilead’s data looked strong enough for remdesivir to receive an emergency use authorization from the agency so that critically ill patients could get the drug quickly. “Remdesivir would appear to meet or exceed standard for authorization under EUA, especially relative to other EUAs issued,” Gottlieb tweeted.

Besides emergency authorizations for a range of tests, FDA last month made the move to hand the authorization to chloroquine and hydroxychloroquine as well despite sparse evidence suggesting they work against the coronavirus.

Zachary Brennan contributed to this report.


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