"Transplant recipients require lifelong immunosuppression, so there is a critical need for treatment regimens that protect the transplanted kidney, and also reduce the side effects and infections associated with calcineurin inhibitors," said Diane M. Cibrik, MD, Associate Professor of Medicine and Medical Director of Transplant Clinical Research Trials at the University of Michigan. "Based on its different mode of action, Zortress offers the ability to reduce calcineurin inhibitors, and may help to address this unmet need."

In 2009, an estimated 16,800 kidney transplants were performed in the US, and an estimated 4,500 kidney transplant candidates died while awaiting organ donation. As of March 2010, there were more than 83,000 patients awaiting kidney transplantation in the US.

Organ survival rates one year after a successful kidney transplant range from 89% when the organ comes from a deceased donor to 95% when the donor is living. However, percentages drop five years after transplantation with survival rates of approximately 67% and 80% respectively.

Zortress has been approved in the US with a Risk Evaluation and Mitigation Strategy (REMS) to help guide patients and healthcare providers on the safe use and risks of Zortress following kidney transplantation. The approved REMS includes a medication guide, a communications plan and a timetable for submission of assessments.

SOURCE Novartis Pharmaceuticals