Positive opinion for Gilead’s Hepcludex

The therapy treats adults with chronic hepatitis delta virus and compensated liver disease

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

The therapy – also known as bulevirtide – treats adults with chronic hepatitis delta virus (HDV) and compensated liver disease.

The drug was initially granted conditional marketing authorisation in 2020, providing patients living with HDV to vital treatments. The CHMP recommendation follows the submission of phase 3 MYR301 week 48 research data, which has reinforced the safety and efficacy profile of bulevirtide.

The positive CHMP opinion is based on a review of pivotal phase 3 data – from week 48 of the MYR301 study – demonstrating the efficacy and safety of bulevirtide, resulting in the removal of the specific obligations related to the conditional marketing authorisation.

The European Commission (EC) will now assess the CHMP recommendation and, if adopted, bulevirtide will be authorised across the EU for the treatment of adults with chronic HDV and compensated liver disease.

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, director, clinic for gastroenterology, hepatology and endocrinology at Hannover Medical School, concluded. “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.”

HDV is the most severe form of viral hepatitis and impacts on around 5% of people living with hepatitis B, with a global prevalence of over 12 million people worldwide. In the US and Europe, it is estimated that there are more than 230,000 people living with HDV and it remains widely under diagnosed.

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