Whilst acknowledging the potential of the drug, a majority of committee members suggested that more prospective data on the Certican/cyclosporine combination regimen is needed to determine the optimal dosage regimen in order to further enhance renal safety. The committee also suggested that therapeutic drug monitoring would be a useful approach to address these issues.
Novartis has initiated further clinical studies in heart transplantation using Certican 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. Data from one of these studies, an on-going European post-marketing study in heart transplantation which may be available for review in 2007, might address the committee’s concerns.
Certican is already approved by most global heath authorities for the prevention of acute rejection in heart transplant recipients.
“While today’s 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 US,” said Giacomo Di Nepi, head of the transplant and immunology business unit at Novartis Pharma AG.