Gilead Submits BLA for Chronic Hepatitis Treatment

November 22, 2021

Gilead Sciences has filed a biologics license application (BLA) with the FDA for bulevirtide, an injectable antiviral for treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.

The BLA was supported by results from several studies, including an ongoing phase 3 trial demonstrating positive safety and efficacy after 24 weeks.

Bulevirtide, which has secured FDA’s Breakthrough Therapy and Orphan Drug designations, was previously granted conditional marketing authorization in Europe as the first treatment for adults with chronic HDV infection with compensated liver disease.

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