Gilead submits Biologics Licence Application to USFDA for Bulevirtide
If approved, Bulevirtide will be the first treatment option for adult patients in the US with chronic Hepatitis Delta Virus infection with compensated liver disease
Gilead Sciences Inc announced recently that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Bulevirtide for injection (2 mg), a potential first-in-class antiviral medicine for the treatment of chronic Hepatitis Delta Virus (HDV) infection in adults with compensated liver disease. Bulevirtide has been granted Breakthrough Therapy and Orphan Drug designations by the FDA, the company said in a statement.
It also said that Bulevirtide is an investigational agent in the US and the safety and efficacy have not been established. The BLA submission is supported by data from completed and ongoing phase-II studies and the ongoing phase-III MYR301 study which supports the safety and efficacy of Bulevirtide 2 mg once daily after 24 weeks of therapy. In Europe, Hepcludex (Bulevirtide) has been granted Conditional Marketing Authorisation by the European Commission and PRIority MEdicines (PRIME) scheme eligibility by the European Medicines Agency (EMA), as the first approved treatment in Europe for adults with chronic HDV infection with compensated liver disease.
“Our goal is to bring safe and effective treatments to people living with the most severe form of chronic viral hepatitis that is associated with rapid progression to serious complications, including fibrosis, cirrhosis and an increased risk of liver cancer and death,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
“As a leader in hepatology, this filing is the latest milestone in Gilead’s ongoing efforts to address the needs of people living with liver diseases and leverages our deep understanding of chronic viral hepatitis. We look forward to working with the FDA with the goal of bringing this innovation to people living with HDV as quickly as possible,” Parsey added.
According to the statement, interim results from the phase-III MYR301 study indicate that after 24 weeks of therapy, the proportion of peo