The US Food and Drug Administration (FDA) has approved Zortress® (everolimus) oral tablets for the prevention of 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 and corticosteroids.
Under the brand name Certican®, everolimus 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."
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.
Calcineurin inhibitors, which are part of the typical immunosuppressive regimen, have been associated with injury to the kidneys and, when used in a combination-immunosuppressant regimen, increase the risk of infections and malignant tumors.
Following transplantation, immunosuppressive medicines are required to protect the transplanted organ from being rejected by the recipient's immune system. Antigen-activated T cells play a key role in transplant rejection by recognizing foreign substances and multiplying in an attempt to protect the body. Zortress acts as an immunosuppressant by binding to a protein called mammalian target of rapamycin (mTOR) and preventing the proliferation of these antigen-activated T cells.