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Regulatory Updates, In Brief

Executive Summary

At last, Novartis' everolimus approved for kidney transplant: FDA approved Novartis' mTOR inhibitor everolimus April 20 for its originally proposed organ transplant setting, as part of an immunosuppressive regimen to prevent rejection in low-to-moderate risk kidney transplant patients. Key to the proliferation inhibitor's approval is the cyclosporine-sparing regimen in which it was tested. Cyclosporine is toxic to kidneys and has been linked to increased risk of infection and malignant tumors. Everolimus, branded Zortress in the U.S. (and marketed as Certican abroad), is to be used in combination with cyclosporine, basiliximab (Novartis' Simulect) and corticosteroids. The approval comes with a Risk Evaluation and Mitigation Strategy that includes a Medication Guide, a communications plan and a timetable for assessments (1"The Pink Sheet" DAILY, Dec. 7, 2009). Though everolimus was cleared in March 2009 as Afinitor to treat advanced renal cell carcinoma and in July 2008 as part of Abbott's drug-eluting Xcience stent, the transplant indications for which Novartis originally aimed had remained elusive. The drug was turned down for use in heart transplants by FDA advisors in 2005, following on "approvable" letters in 2003 and 2004. A resubmission for heart transplantation can't be far away, however. Data from a U.S. Phase III study in heart transplant are expected in 2011, and a global Phase III liver transplant study is ongoing

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