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Novartis receives US FDA approval for Zortress


Patients will be offered a new option which prevents organ rejection and preserves kidney function with reduced doses of cyclosporine.

Surgeons face a major challenge in preventing organ rejection alongside reducing possible side effects when operating on patients in need of a kidney transplant. However, now a new option available for patients, Zortress, may be the answer to their problem.

The US Food and Drug Administration (FDA) has approved Zortress also known as (everolimus) oral tablets for the prevention of organ rejection of kidney transplants in adult patients at low-to-moderate immunologic risk.

Zortress is to be given in combination with reduced doses of the calcineurin inhibitor (CNI) cyclosporine, as well as basiliximab.

Everolimus which is recognised under the brand name
Certican is already an established part of the immunosuppressive regimen for transplant patients in more than 70 countries outside the US.

“For patients who require a kidney transplant, the limited availability of organs underscores the urgent need for effective medicines that can help protect the survival of the transplanted organ for the patient,” said David Epstein, Division Head of Novartis Pharmaceuticals. “Our commitment to transplant patients exceeds 25 years, and Zortress is the latest addition to our growing portfolio. This includes five medications that enable clinicians to provide various treatment options to help manage their individual kidney transplant patients.”

Approval of Zortress was based on results from the largest single Phase III registration study ever conducted in kidney transplant patients. The study revealed Zortress prevented acute organ rejection and preserved kidney function while allowing, on average, 60% lower doses of the CNI cyclosporine to be used compared with the control regimen of mycophenolic acid (MPA) with full dose cyclosporine and corticosteroids. Use of Zortress led to a reduction in CNI-related side effects while maintaining good efficacy.

Diane M. Cibrik, MD, Associate Professor of Medicine and Medical Director of Transplant Clinical Research Trials commented “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,”. “Based on its different mode of action, Zortress offers the ability to reduce calcineurin inhibitors, and may help to address this unmet need.”

Approximately 16,800 kidney transplants in 2009 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.

Kidney transplants on average show high 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.




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