Zortress (everolimus). Zortress is approved by FDA

Zortress (everolimus). Zortress is approved by FDA

Recently Food and Drug Administration US approved the medication Zortress (everolimus) made by the pharmaceutical company Novartis Pharma. Zortress is used to prevent rejection reactions patients with kidney transplantation in adult with low to moderate immunological risk. Zortress should be taken with combination with low doses of cyclosporine. Cyclosporine is immunosuppressor, inhibitor of calcineurin. Zortress should also be used with basiliximab and corticosteroids. The active ingredient of Zortress is Everolimus is currently used in kidney transplantation and heart failure in more than 70 countries outside the U.S. European regulatory approval was received in August 2009; Swiss approval was received in November 2009; Canadian approval in November 2009; and Japanese approval in January 2010. FDA decision is based on the results of the largest Phase III clinical trial involving patients with transplanted kidney. The study showed that Zortress prevents acute rejection and maintain kidney function. The reduction of cyclosporine dose can achieve in average by 60% compared with the control regimen using mycophenolic acid with a full dose of cyclosporine and corticosteroids.

Using Zortress helps to reduce the risk of side effects associated with calcineurin inhibitor intake and maintaining high efficiency of therapy.