BUSINESS: FDA Issues 'Approvable Letter' for Novartis' Certican

BASEL - Novartis Pharma AG has received an "approvable" letter from the U.S. Food and Drug Administration (FDA) for Certican (everolimus) in combination with Neoral (ciclosporin for microemulsion) for the prevention of rejection episodes following heart or kidney transplantation.

The FDA has requested that Novartis provide "additional" information supporting a safe and effective dosing regimen for the combination of everolimus and ciclosporin. The FDA had previously issued an approvable letter for Certican in October 2003 with a request for additional clinical data on dosing regimens. Novartis submitted data in response to the first approvable letter in February 2004. However, the FDA still believes that additional clinical studies on dosing are necessary.

Already approved for use in Europe, Certican is a novel proliferation signal inhibitor with immunosuppressive and antiproliferative properties. It is the latest innovation in the 20-year history of Novartis leadership in transplantation medication. The new drug application to the FDA for Certican included data from one of the most extensive drug development programs conducted to date for a transplantation product.