Gilead submits Biologics Licence Application to USFDA for Bulevirtide

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 people with HDV infection achieving the combined virological and biochemical response was 36.7 per cent with Bulevirtide 2 mg, 28 per cent in participants receiving Bulevirtide 10 mg and zero per cent in participants currently under observation who have not received antiviral treatment at this stage of the study. Treatment for 24 weeks with Bulevirtide 2 mg had a statistically significant response (p<0.001) as compared to the no-treatment group. Additionally, rapid alanine aminotransferase (ALT) reduction and normalisation were observed in >50 per cent of people with HDV in the Bulevirtide 2 mg group compared with the no-treatment group (5.9 per cent). These results reinforce the efficacy of Bulevirtide observed in completed phase-II studies for the treatment of HDV.

Based on these interim results, the safety profile of Bulevirtide at 24 weeks is consistent with previously completed clinical studies. No serious adverse events (AEs), symptomatic elevations in bile salts or AEs leading to discontinuation related to Bulevirtide were reported. The most common AEs observed with Bulevirtide are raised levels of bile salts in the blood (which may affect more than one in 10 people), reactions at the site of injection (which may affect up to one in 10 people) and worsening of liver disease after stopping Bulevirtide (which may affect up to one in 10 people), the statement added.