After FDA rejection, Gilead's Hepcludex looks set for full EU nod

Six months after Gilead got a smackdown in the U.S. for its drug to treat hepatitis delta virus (HDV), bulevirtide has scored a regulatory win in Europe.

The Committee for Medicinal Products for Human Use has given bulevirtide a thumbs-up for patients with HDV and compensated liver disease. If the European Commission signs off on the entry inhibitor, it will become the only authorized treatment for HDV in Europe.

Known commercially as Hepcludex, the drug received conditional approval in Europe three years ago. Since then, a phase 3 trial has demonstrated the effectiveness and safety of the treatment.

Gilead hoped the results of the MYR301 study—which were released in June of last year and showed significant viral declines after 48 weeks of treatment—would pave the way for approval in the U.S.

But the FDA sent Gilead a complete response letter citing manufacturing and delivery concerns. The regulator did not ask Gilead to conduct another trial.

Gilead “remains in active discussions” with the FDA, “with the aim of bringing bulevirtide to people living with HDV in the U.S. as soon as possible," the company said in its release. Bulevirtide has breakthrough and orphan drug designations in the U.S.

The condition is referred to as a satellite virus because it only infects those with hepatitis B. HDV infects roughly 5% of those with HBV, or roughly 12 million worldwide, and is often fatal. The virus is transmitted through broken skin via sexual contact or contact with tainted syringes.

“People living with HDV have had very limited treatment options and without treatment, they often rapidly progress to severe liver disease or liver cancer,” Heiner Wedemeyer, M.D., the director of the clinic for gastroenterology, hepatology and endocrinology at Hannover Medical School, said in a release.

Gilead gained bulevirtide with its 2020 acquisition of German company MYR GmbH for $1.4 billion. The deal came five months after the EMA conditionally endorsed Hepcludex.