Gilead Sciences gets EMA panel postive opinion recommending full marketing nod of Hepcludex for HDV
Foster City: Gilead Sciences, Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Hepcludex (bulevirtide) for the treatment of adults with chronic Hepatitis Delta Virus (HDV) and compensated liver disease, and recommended granting full Marketing Authorisation (MA) that is no longer subject to specific obligations.
Bulevirtide was initially granted conditional marketing authorisation in July 2020 to provide people living with HDV urgent access to treatment. The CHMP recommendation for full Marketing Authorisation of bulevirtide follows the submission of the Phase 3 MYR301 Week 48 study data, which reinforces the efficacy and safety profile of bulevirtide for the treatment of HDV.
HDV is the most severe form of viral hepatitis and affects an estimated 5% of people living with hepatitis B (HBV), with a global prevalence of over 12 million people worldwide. For people living with HDV with advanced disease progression, including cirrhosis, mortality rates can be as high as 50% within five years, presenting significant disease burden and high healthcare-related costs.
“People living with HDV have had very limited treatment options and without treatment, they often rapidly progress to severe liver disease or liver cancer. Until bulevirtide, we have not had any approved options to treat these patients, but we now have a treatment conditionally approved specifically for HDV with a positive recommendation for full approval,” said Heiner Wedemeyer, MD, Director, Clinic for Gastroenterology, Hepatology and Endocrinology at Hannover Medical School. “It gives clinicians additional confidence on the efficacy and safety with longer-term use.”
"The MYR301 Week 48 data supporting this recommendation for full approval demonstrates that with longer treatment with bulevirtide, higher response rates are achieved, meaning this rare, life-threatening disease can be better managed,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “As a company that is a leader in liver disease and virology, we have been committed to improving the lives of people living with viral hepatitis for more than two decades. This marks a significant step forward as it offers real hope to people living with HDV, who have previously faced an uncertain future.”
The positive opinion from the CHMP is based on the review of the pivotal Phase 3 MYR301 Week 48 study data demonstrating the efficacy and safety of bulevirtide, resulting in the removal of the specific obligation related to the conditional marketing authorization. The European Commission (EC) will review the CHMP recommendation, and if adopted, bulevirtide will be fully authorized in the European Union for the treatment of adults with chronic HDV and compensated liver disease.
"Gilead is working with several regulatory authorities on marketing applications for bulevirtide in other parts of the world," the company stated.
In the U.S. bulevirtide was granted Breakthrough Therapy and Orphan Drug designations by the Food and Drug Administration (FDA). While bulevirtide is currently not approved in the U.S.
