US FDA approves Novartis' Zortress for kidney transplant rejection

The US Food and Drug Administration has approved Swiss drug major Novartis' Zortress (everolimus) oral tablets for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk. Zortress is to be given in combination with reduced doses of the calcineurin inhibitor (CNI) cyclosporine, as well as basiliximab and corticosteroids, the company noted.

Under the brand name Certican, everolimus is already an established part of the immunosuppressive regimen for transplant patients in more than 70 countries outside the USA. Everolimus is also available in different dosage strengths under the brand name Afinitor for the treatment of advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib. Afinitor was approved in the USA in 2009, and earned the drug company $41 million in first quarter 2010 sales and $34 million as Certican (The Pharma Letter April 20).