FDAnews Drug Daily Bulletin


Dec. 1, 2005

Novartis' should provide additional safety and efficacy data before the FDA approves its proposed dosing regimen for Certican, suggests the agency's Cardiovascular and Renal Drugs Advisory Committee.

The advisory panel's recommendation came in a close 7-6 vote during a recent meeting to review Novartis' new drug application (NDA) to market Certican in combination with cyclosporine as a prophylaxis against acute rejection in heart transplant recipients.

Although the majority of the committee members agreed that Certican demonstrated superior efficacy compared to similar immunosuppressants, the panel said more prospective data on the Certican/cyclosporine combination regimen was needed to determine the optimal dosage regimen in order to further enhance renal safety. Panel members also noted that therapeutic drug monitoring might be an acceptable way to address these issues.

"While [the] vote by the committee is disappointing and represents a temporary setback, we are encouraged by the supportive statements that many of the committee members made about the Certican program and we are still firmly committed to making Certican available to patients in the U.S.," said Giacomo Di Nepi, leader of Novartis' transplant and immunology business unit.

Novartis has already initiated further clinical studies in heart transplantation using Certican in combination with reduced-dose cyclosporine, and the firm is also conducting therapeutic drug monitoring to supplement the existing clinical registration database from more than 3,000 heart and kidney transplant recipients worldwide.

The approval process has been a lengthy one for Certican, which was first deemed "approvable" by the FDA in October 2003. Novartis received a second approvable letter from the agency in August 2004 requesting that a well-controlled study be conducted with lower doses of cyclosporine to minimize the risk of renal toxicity.