Novartis has received US FDA approval for its immunosuppressive drug Zortress to prevent organ rejection in adult kidney transplant recipients.

The new drug is approved to prevent organ rejection, while reducing the side effects of treatment regimens containing cyclosporine, and to inhibit the proliferation of cells that play a key role in transplant rejection.

Zortress (everolimus) oral tablets will be given in combination with reduced doses of the calcineurin inhibitor cyclosporine, basiliximab and corticosteroids.

In a Phase III registration study, Zortress prevented acute organ rejection and preserved kidney function.

The drug has been available in 70 countries outside the US under the brand name Certican.

Novartis said that an estimated 83,000 patients are awaiting kidney transplantation in the US as of March 2010.

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