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Prof. Stephan Urban led development of the first treatment for hepatitis D, an often-fatal infection for millions of people worldwide.
The FDA cited concerns over the production and delivery of bulevirtide, an investigational, first-in-class hepatitis delta virus entry-inhibitor that received conditional approved in Europe in 2020.
A new immunological treatment against hepatitis B and D viruses, both of which can cause liver cancer, shows promising results in animal models.
“For us in the hepatitis D field, it is a really exciting time; it’s completely novel data and game-changing for patients.”
Data from an ongoing study in patients with compensated cirrhosis and clinically significant portal hypertension have raised hope for an emerging treatment option in this rare, deadly disease.