FDA accelerated approval of Hepcludex significant milestone for US HDV market

Hepcludex is now the first and only approved treatment for HDV patients in the US, marking a significant milestone for the HDV market. Hepcludex is now the first and only approved treatment for HDV patients in the US, marking a significant milestone for HDV patients and the HDV market. Gilead Sciences first submitted a biologics licence application (BLA) to the FDA for Hepcludex in late 2021. Credit: Sundry Photography / Shutterstock.com. Gilead Sciences has announced that the US Food and Drug Administration (FDA) has granted accelerated approval to its antiviral, Hepcludex (bulevirtide-gmod), for the treatment of adults with chronic hepatitis…

Source: Clinical Trials Arena