Novartis' Zortress first drug in over a decade approved by FDA to prevent organ rejection

Swiss drug major Novartis (NOVN: VX) said on Friday that the US Food and Drug Administration has approved Zortress (everolimus), marketed under the trade name Certican outside of the USA, for the prophylaxis of organ rejection in adult patients receiving a liver transplant.

The approval was based on the largest liver transplant study to date, which showed that Zortress plus reduced tacrolimus led to comparable efficacy and 10mL/min higher renal function as measured by estimated glomerular filtration rate (eGFR) for Zortress compared to standard tacrolimus at 12 months.

“Novartis has been a leading innovator in the transplant field for 30 years, and this FDA approval for liver transplantation marks an important milestone for patients and their transplant physicians in the US,” said David Epstein, division head of Novartis Pharmaceuticals. “This second indication for Zortress in just three years in the USA follows the recent European approval, further underscoring Novartis’ continued commitment to bringing much needed treatment options to the transplant community worldwide.”