FDA approves remdesivir to treat hospitalized COVID-19 patients

The Food and Drug Administration yesterday approved Veklury (remdesivir) to treat COVID-19 patients age 12 and older who are hospitalized and weigh at least 40 kilograms (about 88 pounds). The agency said the antiviral treatment should only be administered in a hospital or comparable acute care setting.

“Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic,” said FDA Commissioner Stephen Hahn, M.D.

The antiviral drug previously was available through an emergency use authorization. FDA has revised and reissued the EUA to continue access to the drug for younger and smaller patients while clinical trials assessing its safety and effectiveness in that population continue.