Novartis announced that the FDA has approved Zortress (everolimus) tablets for organ rejection prophylaxis in adult patients receiving a liver transplant. Zortress is the first mTOR inhibitor approved for use following liver transplantation.

The FDA approval was based on a 12-month Phase 3, multicenter open-label, randomized, controlled study conducted in 719 liver transplant patients starting 30 days post-transplant. Results 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.

Zortress is currently indicated for organ rejection prophylaxis in renal transplant patients with low-moderate immunologic risk, in combination with basiliximab induction and reduced doses of cyclosporine and corticosteroids.

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