Remdesivir, a medication tested at University Hospitals, was approved by the U.S. Food and Drug Administration for treatment of COVID-19 patients, according to a May 1 letter from the FDA to Gilead Sciences Inc., the company that developed it.
According to the letter, the drug can be used under the public health emergency declared by the Secretary of Health and Human Services on March 27.
"Based on review of the topline data from the randomized, double-blinded, placebo-controlled trial conducted … it is reasonable to believe that the known and potential benefits of [remdesivir] outweigh the known and potential risks of the drug for the treatment of patients hospitalized with severe COVID-19," according to the letter sent from Denise Hinton, chief scientist at the FDA, to Gilead Sciences.
The letter lays out the rules for use and distribution of the drug, as well as the required notice on the medication that:
• The remdesivir have not been approved;
• The remdesivir have been authorized by the FDA under an emergency use authorization; and
• The remdesivir is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the remdesivir under [federal law] unless authorization is terminated or revoked sooner.
University Hospitals was among the test sites for the medication.
Although the FDA continues to investigate the safety and efficacy of remdesivir, UH stated in a March news release that it had been used in the past by 500 people who received it as a potential treatment of Ebola. In those cases, it proved safe among those receiving the treatment.
According to the FDA, the drug should be administered via IV to patients experiencing serious complications from COVID-19, including limited oxygen in the blood, the need for supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation.
Reporter Bob Gaetjens can be reached at 330-620-8786, email@example.com or @bobgaetjens_rpc.