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.
Source: Chicago Tribune
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