NOVARTIS' CERTICAN TO BE REVIEWED BY FDA ADVISORY PANEL
Novartis' immunosuppressant drug candidate Certican will be reviewed by the FDA's Cardiovascular and Renal Drugs Advisory Committee Nov. 16. The firm is seeking approval of the drug -- in combination with Neoral -- for the prevention of rejection episodes following heart or kidney transplantation.
Novartis submitted a new drug application for Certican (everolimus) in December 2002, but the application has been delayed twice by the FDA, which issued the company approvable letters for Certican in October 2003 and August 2004. Both approvable letters requested additional clinical data supporting a safe and effective dosing regimen for the combination of Certican and Neoral (cyclosporine), an immunosuppressant also manufactured by Novartis.
Certican is already approved for use in Europe as a novel proliferation signal inhibitor with immunosuppressive and antiproliferative properties.
To view the advisory committee meeting notice, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/oc05225-nm00001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/oc05225-nm00001.pdf).