Days after U.S. officials and others reported the first positive controlled data for Gilead’s remdesivir in COVID-19, the FDA has given the drug an emergency use authorization.
President Donald Trump and Gilead CEO Daniel O’Day made the announcement Friday afternoon at the White House, according to CNBC’s Meg Tirrell.
An FDA fact sheet on the emergency authorization says there are no FDA-approved products for COVID-19, but that Gilead’s drug “may benefit certain people in the hospital.” In the FDA’s emergency approval letter, FDA chief scientist Denise Hinton said the emergency nod is warranted because of the lethal nature of COVID-19 and the lack of approved treatments. The emergency approval is limited to patients with severe disease.
“Based on the totality of scientific evidence available to FDA, it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of remdesivir when used to treat COVID-19 outweigh the known and potential risks of such products,” she wrote.
The emergency nod comes two days after a closely watched data release from Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, for a controlled study of remdesivir. In the study, remdesivir cut recovery time for patients hospitalized with COVID-19 by 4 days, or 31%, compared with placebo.
“Although a 31% improvement does not seem like a knockout 100%, it is a very important proof of concept because what it has proven is that a drug can block this virus,” Fauci told reporters at the time.
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While experts believe the medicine won’t amount to a cure, former FDA chief Scott Gottlieb told CNBC it can be part of a “toolbox” for doctors and others to be better prepared to deal with the pandemic.
Gilead has pledged to donate its entire existing supply of remdesivir, and the U.S. government will coordinate distribution of the medicine to hospitals in hard-hit areas.
Gilead’s emergency approval comes as the company and dozens of others study their existing medicines and urgently work on new treatments and vaccines. As of Friday, the pandemic has infected more than 3.32 million people and killed more than 237,000 worldwide.
Meanwhile, authorities in Europe are also said to be reviewing the medicine for a potential emergency use there.