The US Food and Drug Administration (FDA) has approved a new indication for Gilead’s (NASDAQ: GILD) antiviral Veklury (remdesivir), allowing for the treatment of COVID-19 in individuals with mild, moderate, and severe hepatic impairment without the need for dose adjustments. This makes Veklury the only COVID-19 therapy cleared across all stages of liver disease, impacting over 100 million people in the United States.
Phase I Study Supports Approval
The approval is supported by safety and pharmacokinetics results from a Phase I study conducted in individuals with hepatic impairment. This clinical data provides a scientific basis for the expanded use of Veklury in a patient population that has been significantly affected by the pandemic.
Recent Indication Extensions in Europe and the US
The FDA’s decision follows recent indication extensions for Veklury in COVID-19 patients with severe renal impairment in both Europe and the US. These extensions highlight the drug’s versatility in addressing the needs of patients with various health conditions during the ongoing pandemic.-Fineline Info & Tech
