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FDA clears test for Novartis' Zortress

The US Food and Drug Administration has cleared a test that monitors blood levels of Novartis' recently approved immunosuppressant Zortress

The US Food and Drug Administration (FDA) has cleared a test that monitors blood levels of Novartis' recently approved immunosuppressant Zortress (verolimus), a drug that is used to help prevent organ rejection in kidney transplant patients.

Called the QMS Everolimus Immunoassay, the test is made by Thermofisher Scientific. It is the first test to be cleared by the FDA to monitor levels of the drug, which was approved in April 2010 for use in adult kidney transplant patients who are at low-to-moderate immunologic risk.

"Some immunosuppressants are associated with toxic side effects that can injure transplanted kidneys," the FDA explained. "Balancing the levels of immunosuppressants is critical since transplant patients must take these drugs for the rest of their lives."

To secure marketing clearance for the test, Thermofisher compared results obtained from the QMS Everolimus Immunoassay to the results from everolimus reference tests used in the clinical trials of the drug and showed that they were similar.

Novartis' Zortress is an oral tablet designed to help prevent organ rejection and preserve kidney function when used with reduced doses of cyclosporine, an older immunosuppressant with a difficult side effect profile. The new Novartis drug, which works by inhibiting the proliferation of cells that play a key role in transplant rejection, is sold outside the US as Certican.

14th February 2011

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