The U.S. Food and Drug Administration on Friday issued an “emergency use authorization” for the drug remdesivir to treat COVID-19 patients, a fast-tracked approval of a drug that early clinical trial results show can speed recovery.
In a letter Friday to Gilead Sciences, the California-based drug-maker that owns the rights to the drug, the FDA wrote that based on a review of early results of a clinical trial by the National Institute of Allergy and Infectious Diseases (NIAID), and another study by Glead itself, “it is reasonable to believe that the known and potential benefits of RDV outweigh the known and potential risks of the drug for the treatment of patients hospitalized with severe COVID-19.”
Gilead’s investigational antiviral for the treatment of COVID-19 receives @US_FDA Emergency Use Authorization. This more readily enables treatment of hospitalized patients with severe COVID-19 disease in the United States. Read more: https://t.co/p4LR0RM7sI. pic.twitter.com/4kg9oDQPRq
— Gilead Sciences (@GileadSciences) May 1, 2020
The FDA’s emergency use authorization states that the drug can be used in children and adults who are confirmed or suspected CODID-19 cases, who have severe illnesses, low oxygen levels or who are on ventilators.
The NIAID on Wednesday released early results of a worldwide clinical trial, which showed that in a sample of 400 of the overall 1,063 coronavirus patients enrolled in the study, those who received remdesivir, rather than a placebo, recovered 31 percent faster.
The drug was developed with the help of the University of Alabama at Birmingham, which was also selected as one of the sites in the clinical trial. UAB enrolled 16 COVID-19 patients in the clinical trial.
“It’s 31 percent effective over a placebo, which doesn’t sound fantastic, but it is likely going to be saving lives, and it gives the researchers direction on how to target this virus and come up with even better therapies,” said Dr. Paul Goepfert, professor of medicine in the UAB Division of Infectious Diseases and principal investigator in UAB’s clinical trial of the drug, speaking on Wednesday.
According to the FDA’s approval letter to Gilead, the U.S. government will control distribution.
“Gilead will supply remdesivir to authorized distributors , or directly to a U.S. government agency, who will distribute to hospitals and other healthcare facilities as directed by the U.S. Government, in collaboration with state and local government authorities, as needed,” the letter reads.
For 400 of those enrolled in NIAID’s clinical trial, 10 days of treatments with the drug reduced the average hospitalization days time for COVID-19 patients from 15 days to 11.
Dr. Nathan Erdmann, an infectious disease specialist at UAB who oversaw UAB’s patient enrollment in the clinical trial, said during a video conference Wednesday that a handful of the 16 patients are still being treated at UAB, and those of them who were receiving a placebo could soon begin receiving remdesivir instead.