FDA knocks back Novartis' Certican

The Cardiovascular and Renal Drugs Advisory Committee of the US Food and Drug Administration has called for more safety and efficacy data on Swiss drug major Novartis' Certican (everolimus), so delaying its approval as a prophylactic against acute rejection in heart transplant recipients.

Novartis noted that a majority of the committee members agreed that Certican has demonstrated superior efficacy to a comparator in the prevention of acute rejection, and several members also recognized its potential benefits. However, the majority suggested that more prospective data on the Certican/cyclosporine combination therapy was needed to determine the optimal dosage regimen.

Novartis said that the decision "represents a temporary set-back." It has initiated further clinical studies in heart transplantation using the drug in combination with reduced-dose cyclosporine and therapeutic drug monitoring to supplement the existing clinical registration database from over 3,000 heart and kidney transplant recipients worldwide. Several members of the committee suggested that data from an on-going European post-marketing surveillance study in heart transplantation, which may be available for review in 2007, might address its concerns.