May 1, 2020
The U.S. FDA has issued Emergency Use Authorization (EUA) to Gilead’s experimental drug, remdesivir, to treat hospitalized COVID-19 patients. The authorization is based in part on early clinical trial data that suggests the benefits of remdesivir for certain patients may outweigh the risks.
COVID-19 is caused by a novel coronavirus named SARS-CoV-2. Viruses are essentially microscopic packages of genetic information (DNA or RNA) that need a host cell in order to reproduce. Once they’ve infected an organism, they use that organism’s cells to multiply. Remdesivir, originally developed to combat the Ebola virus, works by interrupting this process.
Preliminary data from a clinical trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID) suggests that remdesivir can speed recovery from COVID-19. Compared to placebo, remdesivir shortened time to recovery by 31% (11 days versus 15 days). Patients in the remdesivir arm of the study also had an 8% mortality rate compared to an 11.6% mortality rate in the placebo group. However, this difference in mortality rate is not statistically significant.
Emergency use authorization does not constitute FDA approval of remdesivir for any indication, and is intended only to facilitate access to the drug for patients under certain criteria:
- Patients (adults and children) must have suspected or laboratory confirmed COVID-19 and severe disease, defined as SpO2 (an estimate of the amount of oxygen in the blood) no more than 94% on room air, requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
- Remdesivir must be administered by a healthcare provider in an inpatient hospital setting via intravenous (IV) infusion, and according to the dosing regimens detailed in authorized EUA Fact Sheets.
Distribution of authorized remdesivir will be controlled by the U.S. Government for use consistent with the terms and conditions of the EUA. Gilead will supply remdesivir to authorized distributors or directly to a U.S. government agency, who will distribute it to hospitals and other healthcare facilities as directed by the U.S. government, in collaboration with state and local government authorities, as needed.
Full details of the EUA can be found on the FDA’s website.