The Food and Drug Administration has granted Emergency Use Authorization for the Gilead Sciences, Inc., antiviral drug remdesivir to be used for health care providers to treat suspected or confirmed cases of COVID-19 in adults or children hospitalized with severe disease.
The FDA defines severe disease as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. The FDA says that based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, 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.
Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, said on Wednesday that the preliminary results of the placebo-controlled, randomized clinical trials were very positive, so much so that the oversight board had advised the study team to inform those patients getting the placebo about the preliminary results with an option to switch from the placebo to remdesivir.
The FDA has issued a news release, Health Care Provider Fact Sheet and Patient Fact Sheet.
