FDA gives emergency authorization to COVID-19 drug
The U.S Food and Drug Administration (FDA) has granted emergency use for a new anti-viral COVID-19 drug, remdesivir, being studied in clinical trials at University Hospital.
The announcement was made during an afternoon news conference by President Trump on May 1.
It comes days after the National Institute of Allergy and Infectious Diseases (NIAID) released preliminary results of a national clinical trial showing that the new drug is helping the sickest COVID-19 patients recover more quickly and is preventing deaths.
Thomas Patterson, M.D., professor in the Long School of Medicine and chief of the Division of Infectious Diseases at UT Health San Antonio, is leading a study site in collaboration with University Hospital, where he is leading the COVID-19 Infectious Disease team.
The trial is sponsored by the NIAID and is being conducted at more than 75 sites in the U.S. and a few foreign locations, each under local principal investigators.
“It’s very exciting to be involved in a clinical trial that is moving forward so quickly toward helping patients,” Dr. Patterson said. “This is the first anti-viral drug that has been shown to benefit patients with COVID-19 in a randomized clinical trial.”
With FDA emergency authorization, all hospitalized COVID-19 patients meeting criteria for use can receive remdesivir, which is now the standard of care. The clinical trial will move into what is called the adaptive phase. This means that all hospitalized COVID-19 patients who quality and consent to the study will be given the new drug, and will be randomized to receive additional agents, which are hoped to further improve outcomes. Dr. Patterson said that as other agents are developed, they will be added to remdesivir and evaluated in comparison to remdesivir alone. “We expect to begin the adaptive phase next week,” Dr. Patterson said.
“Remdesivir is not a cure, but it has shown a lot of promise. It has improved recovery time by 31% from 15 to 11 days and improved the death rate from 11.6% to 8%. But 8% mortality is still a lot of people, so the use of additional agents is aimed at further improving outcomes,” he said. The drug acts by disrupting the coronavirus replication process.
“Other new drugs that are being developed might address other processes involved in the illness, like attacking what we call ‘inflammatory storm.’ This is when the body reacts so strongly against the invading virus that it attacks other areas of the body causing, for example, respiratory failure and failure of other organs,” Dr. Patterson said.
So far 20 patients at University Hospital have received remdesivir, Dr. Patterson said.
The international study began Feb. 21 in Nebraska in patients who were quarantined following their return to the U.S. from China. The UT Health San Antonio study site began enrolling University Hospital patients March 26. According to the preliminary findings, overall, 1,063 patients were involved in the study. Approximately half of the patients received remdesivir in an infusion solution while the other group received a placebo solution, with neither patients nor physicians knowing which solution the patient received.
According to an FDA news release, “Gilead CEO Daniel O’Day said remdesivir maker Gilead Sciences is donating 1.5 million vials of the drug and would work with the federal government to distribute it to patients in need.”
Here is a video with reaction from Dr. Jason Bowling, the hospital epidemiologist at University Health System and an assistant professor of infectious diseases at UT Health San Antonio.
UT Health San Antonio is University Health System’s partner in this research study.
Dr. Bowling is part of the team who has been working on the remdesivir clinical trials.
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