Remdesivir Is the First FDA-Approved Treatment for COVID-19

On Oct. 22, the Food and Drug Administration (FDA) approved the first drug for treating COVID-19. Remdesivir, an antiviral medication given intravenously, is now approved for anyone hospitalized with COVID-19. It works by blocking the virus’s ability to make more copies of itself. Earlier this year, the drug had received emergency use authorization (EUA), which falls short of approval but is granted during a public health crisis if there is encouraging data supporting its potential benefits. Approval means the drug’s maker, Gilead, provided more information to the FDA on the medication’s effectiveness and safety than was used to issue the EUA. “This decision by the FDA is a milestone in the treatment of hospitalized patients with COVID-19,” says Dr. Andre Kalil, professor of internal medicine at University of Nebraska Medical Center who was among the first to treat patients from the Diamond Princess Cruise ship with remdesivir and runs one of the drug’s clinical trials. “Remdesivir shortens the recovery time by 5-7 days, provides 50% faster clinical improvement, prevents patients’ progression to mechanical ventilation, and is associated with a 45% mortality reduction in the first two weeks of disease. These are real and meaningful benefits to our patients.” The FDA decision is based on three randomized controlled trials that found that people receiving remdesivir shortened their recovery time. While the data did not find ...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news