FDA Approval of Remdesivir — A Step in the Right Direction | NEJM

On January 31, 2020, the U.S. secretary of health and human services declared a public health emergency in response to Covid-19. This disease, caused by the SARS-CoV-2 virus, can have severe manifestations, including pneumonia, respiratory failure, multiorgan failure, and death. Although there is now an extensive global search for therapies, there remains an unmet need for safe and effective treatment options for patients.

On May 1, 2020, on the basis of preliminary results from phase 3 trials, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow the use of remdesivir for the treatment of suspected or laboratory-confirmed Covid-19 in adult and pediatric patients hospitalized with severe disease.1 The scope of the EUA was subsequently expanded on August 28, to allow use in a broader hospitalized population. On October 22, the FDA approved remdesivir for use in adults and pediatric patients (12 years of age or older and weighing at least 40 kg) for the treatment of Covid-19 requiring hospitalization.2

This approval was based largely on the results of three phase 3 clinical trials in hospitalized patients with disease of varying severity. These were the Adaptive Covid-19 Treatment Trial (ACTT-1) sponsored by the National Institute of Allergy and Infectious Diseases and the supportive trials GS-US-540-5774 and GS-US-540-5773 sponsored by Gilead Sciences. ACTT-1, which had a rigorous design, provided the most compelling evidence of efficacy.