Novartis' Certican has performed well in a late-stage trial in patients with liver transplant, hitting targets of comparable efficacy and improved renal function.
The Swiss drug giant was looking at the effect of introducing its immunosuppressant Certican (everolimus) with reduced exposure tacrolimus one month after liver transplantation compared to that of standard-exposure tacrolimus (the control).
Two-year data from the trial - which the firm notes it the largest Phase III study ever in liver transplantation - showed that the regimen including Certican had comparable efficacy to the control, but also superior renal function maintained over the period.
"These results showed that treatment with Certican with reduced tacrolimus led to a clinically relevant retention of renal function compared to standard tacrolimus, with no compromise in rejection," said John Fung, director of the Transplantation Center at the Cleveland Clinic Foundation.
He also said the news that a treatment regimen of Certican with reduced tacrolimus is "not only possible, but also sustainable" is "exciting" for patients and healthcare professionals, given the concerns over the potential of calcineurin inhibitors - such as tacrolimus - to impair liver function.
Certican was approved by European Health Authorities under the tradename Ceritcan for the prophylaxis of organ rejection in adult patients receiving a liver transplant in October 2012, and a decision by US regulators is expected by the end of the year.
The drug is also sold as Volubia and Afinitor in various indications.