Novartis Pharmaceuticals, based in East Hanover, NJ, has received FDA approval of Zortress (everolimus) oral tablets for preventing rejection of kidney transplants in adult patients at low-to-moderate immunologic risk.
Everolimus is to be given in combination with reduced doses of the calcineurin inhibitor (CNI) cyclosporine as well as basiliximab and corticosteroids.
The approval was based on results from a phase 3 trial showing that the medication prevented acute organ rejection and preserved kidney function. It was associated with an average 60% reduction in cyclosporine doses compared with a control regimen of mycophenolic acid with full dose cyclosporine and corticosteroids. Everolimus use led to a decrease in CNI-associated side effects while maintain good efficacy, according to a Novartis press release.
CNIs have been associated with kidney injury and, when used in a combination immunosuppressant regimen, increase the risk of infections and malignant tumors.
“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 in Ann Arbor. “Based on its different mode of action, Zortress offers the ability to reduce calcineurin inhibitors and may help to address this unmet need.”