Swiss drug giant Novartis (NYSE: NVS ) says the FDA has approved Zortress, its mTOR inhibitor (a protein that controls the growth of tumors and blood vessels)�for�the prevention of organ rejection in adult patients receiving a liver transplant.
It's the first time in over a decade an immunosuppressant has been approved in the U.S. for use following liver transplantation, according to the company.� Previously, Zortress had been approved for kidney transplantation.
The approval was�based on the largest liver transplant study to date, according to Novartis, in which 719 patients started using the drug 30 days after the operation.�Study results showed that Zortress plus reduced tacrolimus led to comparable efficacy and higher renal function compared to standard tacrolimus after a year. Tracrolimus is part of the standard-of-care treatment regimen for immunosuppression in liver transplantation.
European health authorities approved the use of Zortress in the fourth quarter of 2012 and Novartis says it�is one of the most extensively studied immunosuppressants in solid organ transplantation, with more than 10,000 transplant recipients enrolled in Novartis-sponsored clinical trials worldwide.
It is approved in more than 90 countries to prevent organ rejection for renal and heart transplant patients under the trade name Certican.
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