It is expected to be the first innovative hepatitis D therapy approved by the FDA, Gilead submits a regulatory application

On November 19, 2021, Gilead Sciences announced that it has submitted a biologics license application (BLA) for bulevirtide to the US FDA

Hepatitis D is the most serious type of viral hepatitis.

The BLA submission is based on positive data obtained from a Phase 2 clinical trial and an ongoing Phase 3 clinical trial

The interim results of the trial showed that after 24 weeks of treatment, the proportion of patients in the 2 mg bulevirtide group achieving a combined virological and biochemical response was 36.

The safety profile of the drug is consistent with previous studies, and no serious adverse events (AE) have been reported

"Our goal is to provide safe and effective treatments for people with the most severe forms of chronic viral hepatitis, which can quickly progress to serious complications, including fibrosis, cirrhosis, and liver cancer, and increase the risk of death

Reference materials:

[1] Gilead Submits Biologics License Application to US Food and Drug Administration for Bulevirtide, an Investigational Treatment for People Living With Chronic Hepatitis Delta.