ZURICH Swiss pharmaceutical company Novartis said on Monday its Certican, an immune system drug also known under the names Afinitor and Votubia, showed positive outcomes in a two-year phase III study in liver transplantation.
The study, which Novartis said was the largest liver transplant trial to date, confirmed the comparative effectiveness of the treatment and the improved renal function in patients previously noted at the 12-month stage.
The trial evaluated the introduction of Certican (everolimus) with reduced exposure of another immunosuppressive drug tacrolimus administered twice-daily starting one month after liver transplantation versus standard-exposure tacrolimus, Novartis said.
The data were presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
Certican was approved by European health authorities for use in adult liver transplant patients in October 2012. A decision by the US Food and Drug Administration is expected by the end of 2012, Novartis said.
Under the trade name Certican, everolimus is approved in more than 90 countries to prevent organ rejection for renal and heart transplant patients, Novartis said.
(Reporting by Silke Koltrowitz; Editing by Hans-Juergen Peters)