The U.S. Food and Drug Administration (FDA) has approved Hepcludex (bulevirtide) for the treatment of chronic hepatitis D infections. The active ingredient was largely developed by the Heidelberg virologist Prof. Dr. Dr. h.c. Stephan Urban and his team at the Heidelberg Medical Faculty of the University of Heidelberg and the German Center for Infection Research (DZIF).

Hepcludex had already been approved in 2020 as the world’s first drug against hepatitis D in the European Union. With FDA approval, the therapy is now also available on the world’s most important drug market. It is estimated that more than twelve million people worldwide are infected with chronic hepatitis D. This aggressive form of viral hepatitis often leads to liver cirrhosis and liver cancer.

The development of the active ingredient took around 30 years. Stephan Urban first researched the entry mechanisms of hepatitis B and hepatitis D viruses. This gave rise to the concept of an entry inhibitor that prevents the viruses from entering liver cells. The DZIF supported the translational development up to clinical application. The biotech company MYR Pharmaceuticals took over clinical development from phase II onwards. After the EU approval, Gilead Sciences took over the worldwide marketing.

Prof. Dr. Michael Boutros, Dean of the Medical Faculty of Heidelberg, explained that the FDA approval marks an extraordinary success of translational developments. The work of Prof. Urban and his team is an impressive example of the excellence of infection research in Heidelberg and shows how sustainable innovations can emerge from within the faculty.

Prof. Urban emphasized that the development was only possible through long-term, team-oriented work and support, which was not primarily aimed at quick successes. With the FDA approval, a large number of patients in the USA now have access to an effective therapy against an otherwise often fatal disease. The big challenge in the future will be to identify those affected who have not yet been diagnosed and to pave the way to make the drug accessible in low-income countries.

The approval in the USA is another milestone for a therapy that is already available in the European Union, Switzerland, Great Britain, Canada, Russia and Israel. It underlines the importance of translational research and long-term funding structures for the development of new drugs against neglected infectious diseases.

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Editor: X-Press Journalistenbüro GbR

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