Gilead Submits BLA to FDA for Hepcludex (Bulevirtide), the First-in-Class Therapy for Chronic Hepatitis Delta, Already Approved in the EU

News on November 18, 2021 /BioValleyBIOON/ -- Gilead Sciences recently announced that it has submitted to the U.S. Food and Drug Administration (FDA) SubmittedHepcludex（bulevirtide）Biologics License Application (BLA),This drug is a potential first-in-class antiviral medication for the treatment of chronic hepatitis D virus (HDV) infection in adult patients with compensated liver disease.

If approved, Hepcludex will become the first drug regimen in the United States to treat HDV infection in adult patients with compensated liver disease. In the European Union, Hepcludex received conditional approval for marketing in August 2020.This drug is the first therapeutic regimen in Europe for treating HDV infection in adult patients with compensated liver disease.

In December 2020, Gilead Sciences announced the acquisition of MYR GmbH, bringing Hepcludex into its portfolio. In this acquisition, Gilead paid 1.15 billion euros in cash. If Hepcludex receives approval in the United States,FDAApproval: Gilead to Pay €300 Million Milestone Payment

Previously, Hepcludex has been granted Orphan Drug Designation (ODD) for the treatment of HDV infection by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). In addition, Hepcludex has also received Priority Medicines (PRIME) designation from the EMA.FDAGrant Breakthrough Therapy Designation (BTD). The PRIME program is similar to the BTD program, aiming to accelerate the review process of key drugs in areas with drug shortages, benefiting patients as soon as possible. Drugs that receive PRIME or BTD designation must have preliminary clinical evidence showing substantial improvement in clinically significant endpoints compared to existing treatments.

Hepcludex Represents the Most Advanced New Therapy for Hepatitis D in Clinical PracticeThe active pharmaceutical ingredient of this drug is bulevirtide, a first-in-class viral entry inhibitor developed for the treatment of chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) infections. The drug inhibits the HBV/HDV receptor NTCP on the surface of hepatocytes and prevents the infection of regenerating cells and the spread of the virus within the liver.

This BLA submission is based on the results of completed and ongoing Phase 2 clinical studies (MYR202 and MYR203) and the ongoing Phase 3 MYR301 study. The data supports the efficacy and safety of Hepcludex (2mg, once daily) over a 24-week treatment period, demonstrating significant reductions in viremia and improvements in liver function during Hepcludex treatment, with good tolerability and safety.

Interim results from the Phase 3 MYR301 study indicate:After 24 weeks of treatment, 36.7% of HDV-infected patients in the bulevirtide 2mg treatment group achieved virological and biochemical responses, compared to 28% in the bulevirtide 10mg treatment group, and 0% in the untreated observation group.Compared with observation, bulevirtide 2mg treatment for 24 weeks demonstrated statistically significant efficacy (p<0.001). In the bulevirtide 2mg group, more than 50% of HDV-infected patients showed a rapid reduction and normalization of alanine aminotransferase (ALT) compared to the observation group (5.9%). These results reinforce the efficacy of bulevirtide observed in completed Phase 2 studies of HDV treatment.

Based on these interim results, the safety of bulevirtide during the 24-week treatment period was consistent with previously completed clinical studies. No serious adverse events (AEs) related to bulevirtide, symptomatic increases in bile salts, or AEs leading to discontinuation were reported. The most commonly observed adverse events were increased levels of bile salts in the blood (possibly affecting more than 1/10 of patients), injection site reactions (possibly affecting up to 1/10 of patients), and worsening of liver disease after discontinuation of bulevirtide (possibly affecting up to 1/10 of patients). (Bioon.com)

Source of the original text:Gilead Submits Biologics License Application to U.S. Food and Drug Administration for Bulevirtide, an Investigational Treatment for People Living With Chronic Hepatitis Delta