With NICE nod, Gilead clears another regulatory hurdle in Europe for Hepcludex

While Gilead Sciences has struggled to gain approval for its hepatitis delta virus (HDV) treatment bulevirtide in the U.S., it is checking off important regulatory boxes in Europe.  

Monday, the U.K.’s National Institute for Health and Care Excellence (NICE) recommended bulevirtide for the treatment of adults with HDV and compensated liver disease, which is the most aggressive and life-threatening form of hepatitis.

The thumbs-up comes seven months after the FDA rejected bulevirtide due to manufacturing and delivery concerns. The entry inhibitor received orphan-drug status in the U.S. in 2015 and was launched in Europe under the brand name Hepcludex in September 2020 after it received a conditional endorsement.

Earlier this month, Europe’s Committee for Medicinal Products for Human Use recommended bulevirtide for full marketing authorization. The nod came after a phase 3 study showed significant viral declines for patients after 48 weeks of treatment.

The thumbs-up from NICE provides patients in England and Wales their first treatment for HDV. Approximately 1,800 people have evidence of HDV infection in Great Britain, Gilead said.

“While many people have heard of hepatitis C and hepatitis B, today chronic hepatitis D infection is arguably the most aggressive and difficult-to-treat form of viral hepatitis,” Ahmed Elsharkawy of the University of Birmingham said in a release.

When Gilead gained bulevirtide in its acquisition of German company MVR GmbH for $1.4 billion in December 2020, the company said it would “accelerate” its global launch.

Referred to as a “satellite virus,” hepatitis D infects roughly 5% of those with hepatitis B, or roughly 12 million people worldwide. The virus is transmitted through broken skin via sexual contact or contact with tainted syringes.