FDA cleared Novartis’ Zortress® for the prevention of organ rejection in adult kidney transplant patients at low-to-medium immunologic risk. The drug is indicated for administration in combination with a reduced dose of the cyclosporine basiliximab and corticosteroids. U.S. approval comes with a Risk Evaluation and Mitigation Strategy (REMS) to help guide safe use of the drug following kidney transplantation.
Zortress is already available under the Certican® trademark in over 70 countries outside the U.S. for kidney and/or heart transplant patients, Novartis notes. Global sales of the drug were $118 million in calendar year 2009, up 31% on 2008 sales. The Zortress active ingredient, everolimus, is also undergoing Phase III testing in heart transplant patients to support an additional U.S. filing. A worldwide Phase III liver transplant trial is also ongoing.
FDA approval of Zortress was based on data from what Novartis calls the largest single Phase III trial ever conducted in kidney transplant patients. The study showed Zortress therapy prevented acute organ rejection and preserved kidney function while allowing a 60% lower dose of cyclosporine when compared with treatment using mycophenolic acid combined with full-dose cyclosporine and corticosteroids.
The firm says that it now offers five transplant medicines. Neoral/Sandiummun was Novartis’ eight top-selling pharmaceutical in 2009, achieving sales of $919 million (down 1% in local currencies). The transplant medicine Myofortic was also in the company’s top 20. At position 18, it achieved sales of $353 million, up 28% on 2008.
Zortress/Certican is an oral inhibitor of the mTOR pathway. The drug is also available under the brand name Afinitor® for the treatment of advanced renal cell carcinoma after failure of therapy using Sutent or sorafenib. Afinitor was approved in the U.S., Europe, and Switzerland in 2009.
Phase III trials in other cancers are also under way or due to start this year. In Novartis’ annual report for 2009, the firm said that two potential everolimus regulatory submissions are planned for 2010 based on the outcome of clinical trials in patients with neuroendocrine tumors or those suffering tuberous sclerosis complex.