Emergency Use Authorization for Remdesivir

The FDA approved an emergency use authorization (EUA) for remdesivir to treat hospitalized patients with severe COVID-19. The FDA defines severe COVID-19 as patients with low blood oxygen (SpO2 of 94% or less) that require supplemental oxygen with or without a mechanical ventilator or ECMO. The drug is approved to be administered in hospitalized patients. The U.S. Government will control distribution through authorized distributors or government agencies. A Fact Sheet is available for Heath Care Providers that reviews the treatment criteria, dosing, administration and monitoring of the patients receiving the drug. Remdesivir is given for 10 days in patients on ventilators or ECMO. Patients not receiving breathing support are administered the drug for 5 days, which can be extended to ten days if improvement is not seen. A Patient Fact Sheet is also available and must be made available to patients. Remdesivir does not have full FDA authorization and is only approved for use under the EUA for the patients described above.