Pharma Company Gilead Clears Milestone With First Remdesivir Trial

A Palo Alto woman who participated in the first remdesivir trial told Palo Alto Online last week that the drug, which had just been granted emergency apporoval by the FDA, helped her greatly.

“Palo Alto resident Monica Yeung-Arima said on Wednesday that she is gratified by the trial results,” reporter Sue Dremann writes. “Yeung-Arima was given a five-day treatment with remdesivir starting March 13. She began to recover three days into her treatment.”

“I am so glad that I’m one of the guinea pigs,” Yeung-Arima said in a text message to the news organization. “I am getting better every day. I am thankful.”

Foster City-based Gilead Sciences has been making some progress toward getting the COVID-19 treatment to market. U.S. Food and Drug Administration chief scientist Denise M. Hinton sent a letter May 1 to Gilead, granting an emergency use authorization for remdesivir. It is the first drug “to show a clear-cut effect in treating COVID-19,” according to Science Alert.

The approval came following encouraging trial data.

Remdesivir, which was tested at Stanford Medicine, was shown to speed COVID-19 recovery times by 31 percent.

“Although a 31 percent improvement doesn’t seem like a knockout 100 percent, it is a very important proof of concept,” National Institute of Allergy and Infectious Diseases director Anthony Fauci said during an April 29 news briefing at the White House, according to Science News.

Fauci added, “It has proven that a drug can block this virus.”

There are conditions with the approval, though. 

The letter noted various stipulations for Gilead, including that the 33-year-old company “maintain records regarding distribution of the authorized remdesivir” and that Gilead supply the FDA upon request any records maintained in connection with the authorization.

The FDA also said remdesivir had authorization only for the duration of a declaration made March 27 by U.S. Secretary of Health and Human Services Alex Azar “that circumstances exist justifying the authorization of emergency use of drugs and biologics during the COVID-19 outbreak.”

There also have been some questions about remdesivir’s path to approval, with the website StatNews.com asking if it were fair that the study’s main goal changed prior to the FDA issuing its authorization.

“It’s a big concern—and hypothetically could have affected how trial results were interpreted,” Matthew Herper wrote. “It could be all the more concerning because the Food and Drug Administration used the data as the basis to authorize emergency use of remdesivir.”

Herper noted that the institute has insisted that it changed the goals of the study blindly and before any data was revealed.

In any event, Gilead’s work toward a vaccine over the past couple of months has been to its benefit, with its stock price rising more than 20 percent since the beginning of February. 

The company will undoubtedly face continued competition among various other pharmaceutical companies racing to complete a full vaccine for COVID-19, with NBC News reporting May 5 that Pfizer and New York University hope to have a vaccine out by the end of summer.