EMA approves Zutectra (subcutaneous hepatitis B immunoglobulin) for use after liver transplantation- Biotest AG

The European Commission has granted marketing approval to Biotest for the early use of the hepatitis B immunoglobulin Zutectra after liver transplantation. Before, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had adopted a positive opinion for the modification of the indication in November 2015. While Zutectra could be administered 6 months after liver transplantation so far, the subcutaneous hepatitis B immunoglobulin can now be applied already one week after liver transplantation. The positive assessment is based on the clinical results of the Early-Use-Study (ZEUS) demonstrating the effective use of Zutectra in the early phase after liver transplantation. The international clinical phase III Zutectra Early Use Study (ZEUS) demonstrates effective and safe switch from high dose intravenous hepatitis B immunoglobulin (HBIG) to subcutaneous HBIG, Zutectra, at the early phase after liver transplantation.

Early administration of Zutectra contributes significantly to a safe, more time efficient, less costly patient care and better convenience for the patient. This enables patients' training for self-medication already during hospitalisation.