FDA Approval of Certican™ Sought for Heart and Kidney Transplant Patients

Novartis Pharmaceuticals Corporation announced it has applied to the U.S. Food and Drug Administration (FDA) for approval of Certican™ (everolimus) for prevention of rejection episodes following heart and kidney transplants.

The company said clinical studies that have followed more than 1,500 heart and kidney transplant recipients for up to 36 months showed that Certican, when used with cyclosporine and steroids, effectively helped prevent organ rejection.

Certican is a proliferation inhibitor with immunosuppressant properties that targets primary causes of rejection. Novartis submitted an application to market Certican in Europe earlier in the year.

Other sources: Novartis