FDA OKs New Veklury Covid Indication

FDA has approved a Gilead sNDA for the use of Veklury (remdesivir) with no dose adjustments to treat Covid-19 in people with mild, moderate, and severe hepatic impairment. A company statement says the approval supports Veklury’s position as the only approved antiviral Covid-19 treatment that can be used across all stages of liver disease.

The approval was based on results from a Phase 1 study of safety and pharmacokinetics in people with hepatic impairment, Gilead says. The drug’s labeling has been updated to reflect that no dose adjustment is required across all stages of liver disease, it says.

Veklury is indicated to treat Covid-19 in adults and pediatric patients who are (1) hospitalized or (2) not hospitalized and have mild-to-moderate Covid-19 and are at high risk for progression to severe Covid-19, including hospitalization or death.