- The Zutectra-Early-Use-Study (ZEUS) demonstrates safe and effective switch from high dose intravenous hepatitis B immunoglobulin (HBIG) to subcutaneous HBIG, Zutectra®, at the earliest one week after liver transplantation
- No Hepatitis B virus reinfection after six months of Zutectra® prophylaxis with excellent safety and tolerability data
- Data presented at the 50th International Liver Congress 2015 in Vienna, Austria
- Zutectra® dossier submitted to European Medicines Agency (EMA) for EU-Approval
DREIEICH, Germany I April 23, 2015 I Biotest presents today the efficacy and safety results from the Zutectra-Early-Use-Study (ZEUS) at the 50th International Liver Congress 2015 in Vienna, Austria.
The international clinical phase III study was performed in 17 transplant centers in four of the Big-Five EU-Markets, Italy, Spain, France and United Kingdom. Zutectra® was administered subcutaneously combined with hepatitis B Virus virostatic therapy ‘8 – 18’ days after transplantation preventing hepatitis B Virus (HBV) re-infection in patients at risk for hepatitis B virus recurrence.
47 adult patients suffering from life-threatening terminal liver disease due to long-lasting chronic hepatitis B or HCC (hepatocellular carcinoma) completed the study. There were no treatment failures and no clinical signs of a hepatitis B virus reinfection were observed. There were no treatment related serious-adverse-events (SAE) and only one treatment related but non-serious adverse-event (AE), a mild and transient hematoma at the injection site.
With the Zutectra-Early-Use-Study Biotest successfully extends the medical application of Zutectra® to allow the earliest conversion to subcutaneous administration. This contributes concomitantly to a safe, more time efficient, less costly patient care and better convenience for the patient.
Biotest submitted the dossier for “Zutectra-early-use” after liver transplantation to the EMA for EU-approval. The approval process is expected to be finalized in Q4 2015.
About Zutectra®:
Zutectra® was specifically developed by Biotest for the long-term treatment of patients after liver transplantation. It is worldwide the first ready-to-use hepatitis B immunoglobulin solution in a pre-filled syringe for subcutaneous administration and it enables patients to self-medication. This provides the attending physicians and patients with a less-painful, time-saving and simpler treatment option.
The European Commission has granted marketing approval to Biotest for the hepatitis B immunoglobulin Zutectra® in 2009. Zutectra® is currently marketed in the EU member states and major ROW markets.
SOURCE: Biotest
Post Views: 152
- The Zutectra-Early-Use-Study (ZEUS) demonstrates safe and effective switch from high dose intravenous hepatitis B immunoglobulin (HBIG) to subcutaneous HBIG, Zutectra®, at the earliest one week after liver transplantation
- No Hepatitis B virus reinfection after six months of Zutectra® prophylaxis with excellent safety and tolerability data
- Data presented at the 50th International Liver Congress 2015 in Vienna, Austria
- Zutectra® dossier submitted to European Medicines Agency (EMA) for EU-Approval
DREIEICH, Germany I April 23, 2015 I Biotest presents today the efficacy and safety results from the Zutectra-Early-Use-Study (ZEUS) at the 50th International Liver Congress 2015 in Vienna, Austria.
The international clinical phase III study was performed in 17 transplant centers in four of the Big-Five EU-Markets, Italy, Spain, France and United Kingdom. Zutectra® was administered subcutaneously combined with hepatitis B Virus virostatic therapy ‘8 – 18’ days after transplantation preventing hepatitis B Virus (HBV) re-infection in patients at risk for hepatitis B virus recurrence.
47 adult patients suffering from life-threatening terminal liver disease due to long-lasting chronic hepatitis B or HCC (hepatocellular carcinoma) completed the study. There were no treatment failures and no clinical signs of a hepatitis B virus reinfection were observed. There were no treatment related serious-adverse-events (SAE) and only one treatment related but non-serious adverse-event (AE), a mild and transient hematoma at the injection site.
With the Zutectra-Early-Use-Study Biotest successfully extends the medical application of Zutectra® to allow the earliest conversion to subcutaneous administration. This contributes concomitantly to a safe, more time efficient, less costly patient care and better convenience for the patient.
Biotest submitted the dossier for “Zutectra-early-use” after liver transplantation to the EMA for EU-approval. The approval process is expected to be finalized in Q4 2015.
About Zutectra®:
Zutectra® was specifically developed by Biotest for the long-term treatment of patients after liver transplantation. It is worldwide the first ready-to-use hepatitis B immunoglobulin solution in a pre-filled syringe for subcutaneous administration and it enables patients to self-medication. This provides the attending physicians and patients with a less-painful, time-saving and simpler treatment option.
The European Commission has granted marketing approval to Biotest for the hepatitis B immunoglobulin Zutectra® in 2009. Zutectra® is currently marketed in the EU member states and major ROW markets.
SOURCE: Biotest
Post Views: 152
