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The acquisition will provide Gilead with Hepcludex™ (bulevirtide), which was conditionally approved by the European Medicines Agency (EMA) for the treatment of chronic HDV infection in adults with compensated liver disease in July 2020.
On July 31st HEPCLUDEX® was granted Conditional Marketing Authorization (CMA) by the European Commission as the first approved treatment in Europe for adult patients with chronic hepatitis delta virus (HDV) infection and compensated liver disease.
HEPCLUDEX® has been approved as the first treatment option for adult patients with chronic hepatitis delta virus infection and compensated liver disease in Europe.