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A drug has been approved for use in the US to help prevent the rejection of kidney transplants in adult patients.
Zortress, or everolimus, oral tablets were given the all clear to be used in this capacity by the US Food and Drug Administration (FDA).
The drug has been developed by Novartis and will be used on patients at low-to-moderate immunologic risk. Its use will help to reduce the normal doses of the calcineurin inhibitor cyclosporine, as well as basiliximab and corticosteroids, which will continue to be administered along side it.
Under the brand name Certican, everolimus is already a popular drug for the suppression of immune systems for transplant patients outside the US, with more than 70 countries using it.
Approval of Zortress followed an extensive Phase III registration study in kidney transplant recipients. Results showed the drug prevented acute organ rejection and preserved kidney function while allowing, on average, 60% lower doses of the calcineurin inhibitor cyclosporine to be used compared with the control regimen of mycophenolic acid with full dose cyclosporine and corticosteroids.
This also had the added benefit of reducing calcineurin inhibitor-associated side effects.
Copyright Press Association 2010
Novartis