Novartis receives landmark US approval for Certican

Novartis' everolimus-based product Certican has become the first agent approved for the prophylaxis of organ rejection in adult patients receiving a liver transplant in the US for more than a decade.

The compound, which is sold overseas under the name Zortress, is the first mammalian target of rapamycin inhibitor approved for use following liver transplantation and was accepted for this indication in Europe in the fourth quarter of 2012.

A prior study showed that Certican plus reduced tacrolimus led to comparable efficacy and superior renal function levels among patients than standard tacrolimus at 12 months.

Zortress is already approved for use in adult kidney transplant patients in the US, while Certican has been ratified for use among kidney and heart transplant recipients in Europe.

David Epstein, division head of Novartis Pharmaceuticals, said: "This second indication for Zortress in just three years in the US follows the recent European approval, further underscoring Novartis' continued commitment to bringing much needed treatment options to the transplant community worldwide."

Last month, the company achieved a further regulatory milestone when its meningococcal serogroup B disease vaccine Bexsero was approved by the European Commission.