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Positive opinion for Gilead’s Hepcludex

The vital recommendation ensures marketing authorisation for treating the hepatitis delta virus.

Gilead Sciences has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided a positive opinion for Hepcludex.

Also known as bulevirtide, the therapy concerns adults with chronic hepatitis delta virus (HDV) and compensated liver disease. Meanwhile, the recommendation grants full marketing authorisation (MA) which will no longer be subject to certain obligations.

Initially, Bulevirtide was granted conditional marketing authorisation in 2020 in order to treat particular HDV patients who required urgent access to treatment. The CHMP recommendation for full MA of bulevirtide arrives after the submission of phase 3 MYR301 week 48 study data, which reinforces its safety and efficacy profile.

HDV remains the most severe form of viral hepatitis and impacts around 5% of people living with hepatitis B (HBV). Furthermore, there is a prevalence of over 12 million people worldwide.

For those people managing HDV with advanced disease progression – including cirrhosis – mortality rates can be as high as 50% within five years. This equates to significant disease challenges and increased healthcare-related costs.

Frank Duff, Senior Vice President, Virology Therapeutic Area Head at Gilead Sciences, reflected: “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.”

He added: “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.”

Heiner Wedemeyer, the Director of, the Clinic for Gastroenterology, Hepatology and Endocrinology at Hannover Medical School, added: “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. It gives clinicians additional confidence on the efficacy and safety with longer-term use.”

Ultimately, the European Commission will review the new CHMP recommendation and, if successful, bulevirtide will be fully authorised in the European Union for adults with chronic HDV and compensated liver disease.