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Posts Tagged ‘organ donor’

Zortress??: A New Drug To Prevent Organ Rejection

by admin on: October 12th, 2011

Zortress is a new drug that helps prevent organ rejection in patients receiving a kidney transplant. This drug (manufactured by Novartis) was approved by the U.S. Food and Drug Administration (FDA) in April 2010, and used as an adjunct therapy with reduced doses of a calicneruin inhibitor (CNI) such as cyclosporine, basilizimab and corticosteroids. Zortress has been available outside the U.S. as the drug Certican.

Prior to approval of this pharmacologic agent, the FDA reviewed the results of the Phase III clinical study of Zortress. This clinical study was the largest study conducted to date using patients involved in kidney transplant surgeries. The results of this clinical study indicated that patients receiving Zortress avoided acute organ rejection and were able to retain kidney function. In addition, patients receiving Zortress were able (on average) to be placed on lower doses of the CNI cyclosporine than patients who were given thecontrol regimen, which wasmycophenolic acid (MPA). These patients required full doses of cyclosporine and corticosteroids. As with most pharmacologic drugs, lower doses result in fewer adverse side effects. Therefore, not needing a full dose of CNI is yet another advantageZortress provides.

After a patient receives an organ transplant, it is necessary to administer immunosuppressive medicines so that the transplanted organ is protected from the recipient???s immune system. One of the key immune system cell types that would reject the transplanted organ is antigen-activated T-cells.Zortress works bybinding to a protein called mammalian target of rapamycin (mTOR) and, by doing so, it prevents the proliferation of the antigen-activated T-cells.

Due to the fact that patients receiving organ transplants require lifelong immunosuppression, medicines such as Zortress fill a critical need for treatment regiments. In addition, drugs such as Zortress that can effectively reduce the dose of other drugs (thereby reducing the unwanted side effects) provide a better quality of life for organ transplant patients.