Novartis reports positive data from phase III Certican trial

Novartis has reported positive data showing how its drug Certican can help deliver positive outcomes for liver transplant patients.

During the largest phase III study ever in liver transplantation, it was shown that Certican plus reduced-exposure tacrolimus provided comparable efficacy to standard-exposure tacrolimus, while delivering superior renal function.

This is an important finding, as calcineurin inhibitors such as tacrolimus – which are currently part of the standard immunosuppression regimen after a liver transplant – may contribute to a decline in renal function over time.

Certican was approved for the prophylaxis of organ rejection in adult liver transplant patients last month, with a decision by the US Food and Drug Administration expected before the end of the year.

Tim Wright, global head of development for Novartis Pharma, said: "The promising renal function results seen in this study represent yet another potential advance for patients and build upon the recent approval of Certican for adult liver transplant patients by the European health authorities."

Last month, the company announced data from a clinical trial of the multiple sclerosis therapy Gilenya, which demonstrated its sustained efficacy and long-term safety profile.