The FDA announced today it will grant emergency use authorization to Gilead Sciences' remdesivir, a drug that showed early promise in treating coronavirus disease 2019 (COVID-19).
Earlier this week, preliminary data from an NIH trial found the treatment accelerated recovery in individuals with advanced COIVD-19 and lung involvement. The investigational antiviral drug is now authorized "for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease."
The FDA notes there is limited information on the safety and effectiveness of the treatment, which can only be administered intravenously by healthcare providers. Patients with low blood oxygen levels, or who need oxygen therapy, or more intensive breathing support from a mechanical ventilator fall under the "severe disease" category.
Trial results showed patients who received the treatment had a 31% faster recovery time compared with those who received placebo (P <.001). This amounted to a recovery time of 11 days in the intervention cohort compared with 15 days in the control group. “Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (P = .059),” the researchers noted.
"FDA’s emergency authorization of remdesivir...is a significant step forward in battling COVID-19 and another example of the Trump Administration moving as quickly as possible to use science to save lives,” said HHS Secretary Alex Azar.
The National Institute of Allergy and Infectious Diseases (NIAID) sponsored the Adaptive COVID-19 Treatment Trial (ACTT), which was specifically designed to incorporate additional investigative treatments as the pandemic progresses.
An independent data and safety monitoring board (DSMB) found “remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials.” The researchers defined recovery as patients being well enough for hospital discharge or returning to normal activity level.
However, the study has yet to be peer reviewed and a separate placebo-controlled multicenter study published April 29, found remdesivir offered no benefit to patients with COVID-19. “In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits,” researchers concluded.
"The known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use," the FDA stated.
Wang Y, Zhang D, Du G, et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial [published online April 29, 2020]. J Lancet. doi:10.1016/S0140-6736(20)31022-9.