Novartis will decide how to pursue a Certican development program by the first week of September following receipt of a second FDA "approvable" letter, the company said.

FDA deemed Certican (everolimus) approvable Aug. 27 for use in combination with Neoral (cyclosporine) for the prevention of rejection episodes following heart or kidney transplantation. Novartis plans to respond to the letter within 10 days.

Certican was first approvable at FDA Oct. 20, 2003. The agency requested additional clinical data on dosing regimens for Certican in combination with Neoral.

Novartis' response to the first approvable letter was submitted in February 2004. A Certican dosing study had been underway when the company received the letter.

The recent action letter recommends further clinical investigation of lower Neoral dosing for combination use with Certican, Novartis said.

Suggested dosing in Neoral labeling is 7 (plus or minus 3) mg/kg/day for heart transplant patients and 9 (plus or minus 3) mg/kg/day for renal transplant patients.

Novartis submitted the NDA for Certican on Dec. 20, 2002.

- Adam Eckstein

Novartis' Certican Requires Further Dosing Studies, FDA "Approvable" Letter Says

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