The U.S. Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for the antiviral drug remdesivir to treat hospitalized patients with coronavirus. It is the first approved therapy drug for COVID-19 in the United States.
What is remdesivir?
Remdesivir is a broad spectrum antiviral agent, developed by Gilead Sciences. It was previously tested in humans infected with Ebola and has shown promise in treating Middle East respiratory syndrome (MERS) as well as severe acute respiratory syndrome (SARS), which are two diseases caused by other coronaviruses.
The optimal duration of treatment by remdesivir is still being studied in ongoing clinical trials, according to a press release from Gilead. Under the EUA, both five-day and 10-day treatment durations are suggested, based on the severity of disease.
Research offers hope
Finding an effective treatment for COVID-19 has been an arduous process. But the new investigational agent has shown promise, according to a preliminary data analysis from the National Institute of Health.
Early results of the NIH’s Adaptive COVID Treatment Trial (NIH) showed a 31 percent faster recovery time for patients who received remdesivir, compared to those who received a placebo. The trial included 1,063 patients and was conducted at 68 sites― 47 in the United States and 21 in countries in Europe and Asia.
The median recovery time was 11 days for patients in the remdesivir group versus 15 days for those in the placebo arm of the study. In addition, the results suggested a possible survival benefit: Remdesivir was associated with a mortality rate of eight percent, compared to 11 percent with the placebo.
A need for clarity
The results of another study, published in The Lancet, showed somewhat conflicting findings. Conducted across 10 hospitals in Hubei, China with a cohort of 237 coronavirus patients, the researchers observed no statistically significant benefit for remdesivir treatment beyond standard of care. However, patients with symptom duration of 10 days or less who received remdesivir had a numerically faster time to clinical improvement than those who received a placebo.
The researchers said the numerical reduction in recovery time requires confirmation in larger studies.
The outlook on care
At this point, it’s not entirely clear how effective the drug will be in fighting the virus. The FDA has acknowledged there is limited information about remdesivir’s safety and effectiveness of use. But some health experts are hopeful, and the authorization allows remdesivir to be distributed to providers for administration.
The U.S. government will coordinate the donation and distribution of remdesivir to hospitals in cities most heavily impacted by COVID-19, according to the statement from Gilead. Given the severity of illness and the limited availability of drug supply, hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution of the drug.
- FDA May Announce Emergency Use of Gilead’s Coronavirus Drug on Wednesday, New York Times.
- NIH Clinical Trial Shows Remdesivir Accelerates Recovery from Advanced COVID-19, NIH.
- Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial, The Lancet.
- Dr. Anthony Fauci says Gilead’s remdesivir will set a new ‘standard of care’ for coronavirus treatment, CNBC.