Novartis Gets FDA Approval For Zortress

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

The active ingredient in Zortress is everolimus, which was first approved in 2003 under the brand name Certican and is used for kidney and heart transplantation in more than 70 countries outside the US. A Phase III study using everolimus in heart transplant is under way to support US filing, and a worldwide Phase III liver transplant study is ongoing.

Novartis Pharma said that FDA approval of Zortress was based on results from the largest single Phase III registration study ever conducted in kidney transplant recipients.

In the study, 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-associated side effects while maintaining good efficacy.

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.

Diane Cibrik, associate professor of medicine and medical director of transplant clinical research trials at the University of Michigan, said: “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.”