FDA Set to Grant Emergency Approval for Drug Remdesivir for Treating Coronavirus

The US Food and Drug Administration is reportedly set to authorize the use of anti-viral drug remdesivir for the treatment of the coronavirus, The New York Times reports. Although the FDA has not yet approved any drugs for COVID-19 treatment, the agency reportedly plans to announce an emergency-use authorization for remdesivir. On Wednesday, The Times reported that the authorization could come any day, citing a senior administration official.

Just before stock markets opened Wednesday, Gilead, the maker of the drug, announced that it was "aware of positive data" about the drug's performance in a federal trial, sending stocks soaring. Later, in a briefing at the White House, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the trial had shown that treatment with the drug could modestly speed recovery in patients infected with the coronavirus. Fauci noted that the improvement in recovery times "doesn't seem like a knockout 100 percent," but "it is a very important proof of concept, because what it has proven is that a drug can block this virus."

The FDA also confirmed to CNN that it is in talks with Gilead about making the drug available to patients. "As part of the FDA's commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in ... discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate," FDA spokesman Michael Felberbaum said in statement.

The government-funded study found that patients who took remdesivir recovered faster than patients who did not. Results from the preliminary trial show remdesivir improved recovery time for coronavirus patients from 15 to 11 days — similar to the effect that the influenza drug Tamiflu has on the flu. Tamiflu does not cure patients quickly, but can reduce how long they are sick.

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Federal officials are keen to provide any hope they can in the pandemic that has infected more than 1 million Americans and killed close to 60,000 of them. Normally, data about a drug's efficacy wouldn't be released this early from a preliminary trial. But "whenever you have clear-cut evidence that a drug works, you have an ethical obligation to immediately let the people in the placebo group know so that they can have access," Fauci said.

The World Health Organization said it's too early to comment on the remdesivir trial results released Wednesday. "Typically, you don't have one study that will come out that will be a game-changer," Dr. Maria Van Kerkhove, the WHO's technical lead for the coronavirus response, told CNN. She said the agency generally pulls together evidence from several studies before reviewing and critiquing the evidence. "It can sometimes take a number of publications to determine [what] the ultimate impact of a drug is," said Dr. Mike Ryan, executive director of the WHO's health emergencies program.