COVID-19: FDA grant remdesivir emergency use after turbulent week

They are being studied in clinical trials for COVID-19, and we authorized their temporary use during the COVID-19 pandemic for treatment of the virus in hospitalized patients when clinical trials are not available, or participation is not feasible, through an [EUA],” the FDA statement reads. According to the researchers, remdesivir stops the replication process in their model of the coronavirus that causes MERS.On February 25, 2020, the NIH began enrolling people into their remdesivir clinical trial to test the drug’s safety and efficacy in the treatment of COVID-19. In 18 participants, the researchers stopped the drug treatment due to adverse reactions.What did the results say about the efficacy of the drug for treating COVID-19?“Remdesivir use was not associated with a difference in time to clinical improvement,” write the authors in the paper. However, also on April 29, 2020, the National Institute of Allergy and Infectious Diseases (NIAID) announced that their NIH trial showed that remdesivir treatment led to faster recovery in hospital patients with COVID-19, compared with placebo treatment. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”On May 1, 2020, the FDA gave the go-ahead for clinicians to use remdesivir outside of clinical trials to treat COVID-19 in certain people.“Today, the [FDA] issued an [EUA] for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease,” a press statement reads. “While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.”EUA is a type of approval that the FDA can issue for a medical product in situations that are serious or life threatening.