The U.S. Food and Drug Administration has issued an emergency order to speed up the delivery of an antiviral drug called remdesivir that’s being tested for the treatment of patients severely ill with COVID-19, the disease caused by the coronavirus.
Within the next few days, the federal government will start to dole out vials of the drug to hospitals.
But the drug won’t be easy for doctors to get their hands on — even in San Antonio where the drug’s efficacy is being tested at two federally funded clinical trial sites.
The FDA’s order came on Friday, just two days after the drug produced by Gilead Sciences was reported to have shown to shorten COVID-19 patients’ recovery time by 31 percent in a randomized, controlled trial that began on Feb. 21.
“They saw that significantly more recoveries happened in the patients who took remdesivir than the placebo, and so much so that it was statistically and clinically significant,” said Dr. Thomas Patterson, chief of UT Health San Antonio’s infectious disease division and leader of the portion of the trial at University Hospital.
Preliminary results showed remdesivir shortened recovery time to 11 days compared with 15 days with a placebo.
The results also suggested fewer patients died after receiving the drug, with a mortality rate of 8 percent for the group receiving remdesivir versus 11.6 percent for the placebo group, Patterson said.
He began enrolling patients diagnosed with the coronavirus in the clinical trial in late March.
His team of investigators are responsible for 20 of the 1,063 patients enrolled in the Adaptive COVID-19 Treatment Trial, sponsored by the National Institute of Allergy and Infectious Diseases, part of National Institutes of Health.
Patients have also been treated with the drug at Brooke Army Medical Center at Fort Sam Houston, but the number of patients enrolled at that site wasn’t available Monday.
The drug must be administered intravenously and the optimal dosing is still unknown.
Gilead Sciences, a biopharmaceutical company based in Foster City, Calif., donated its entire supply last week — 1.5 million vials, or enough for about 140,000 patients. It also set a goal of producing at least 500,000 treatment courses by October.
Monday afternoon, the World Health Organization said it would discuss with the U.S. government and Gilead how to make the drug widely available to other countries fighting the pandemic.
Remdesivir had been previously tested in humans for Ebola and had also shown promise in animal studies for treating MERS and SARS, which, like COVID-19, are also caused by coronavirus strains.
The FDA’s “emergency use authorization” is not a formal approval, Patterson says, but it will allow health care providers to start to use the drug to shorten the recovery time for patients and could save lives.
But he worries about whether there will be enough of the drug to get to the patients who really need it.
“There just is not enough to support everyone’s needs,” said Elliott Mandell, senior vice president and chief pharmacy officer for University Health System.
He expects a surge in demand as the U.S. government distributes the drug to hospitals in cities most heavily impacted by COVID-19, which so far hasn’t been San Antonio.
“Everyone is expecting a second wave once the warmer season is over, akin to the flu,” Mandell said. “Still unknown is the impact that continued lifting of restrictions to open the economy will have on spread.”
The coronavirus pandemic has resulted in more than 1.1 million confirmed cases and killed 68,326 people in the United States, according to Johns Hopkins University, which tracks cases based on data from the Centers for Disease Control and Prevention and public health departments.
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UT Health’s Patterson said the clinical trial is ongoing. In the next phase, investigators will add another drug, called baricitinib, to be taken in combination with remdesivir.
Baricitinib is a rheumatoid arthritis drug made by Indianapolis-based pharmaceutical giant Eli Lilly and Co.
Laura Garcia covers the health care industry in the San Antonio and Bexar County area. To read more from Laura, become a subscriber. email@example.com | Twitter: @Reporter_Laura