Novartis Receives 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.
Novartis 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 percent 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.
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.
How far this approval will help Novartis?
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