FDA Approves Remdesivir for COVID-19 in People with Mild-to-Severe Hepatic Impairment, & No Dose Adjustment

Publicly traded Gilead Sciences, Inc. (Nasdaq: GILD) reports in the media that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury® (remdesivir) with no dose adjustments to treat COVID-19 in people with mild, moderate and severe hepatic (liver) impairment. The company positions the approval as evidence of the regulatory only further bolstering the drug’s safety profile, and its brand as the first and only approved antiviral COVID-19 treatment that can be used across all stages of liver disease reports the company. The road to remdesivir acceptance around the world wasn’t straight forward.  

All sorts of problems occurred early on with this drug. From the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) changing the goal post in a critical trial leading to the initial emergency use authorization (EUA) and ultimate FDA approval to questionable expedited processes. See TrialSite’s “Not a ‘Knock out’ Drug but Knocking it out of the Ballpark: Gilead Windfall as Remdesivir COVID-19 Sales to Hit $1-to-3 Billion in 2020.”