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Zortress (Everolimus) Gets FDA Nod to Prevent Organ Rejection After Liver Transplant

First drug approved for this indication in more than a decade (Feb. 15)

The FDA has approved Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a liver transplant. According to the drug’s developer (Novartis), Zortress is the first mammalian target of rapamycin (mTOR) inhibitor approved for use following liver transplantation and is the first immunosuppressant approved by the FDA for more than a decade for use in this setting.

The approval was based on results from a phase III, open-label, randomized controlled study in 719 liver transplant patients. At 12 months, treatment with Zortress (everolimus) plus reduced tacrolimus led to comparable efficacy and 10-mL/min higher renal function — as measured by the estimated glomerular filtration rate (eGFR) for Zortress — compared with treatment with standard tacrolimus.

Calcineurin inhibitors (CNIs), such as tacrolimus, are part of standard-of-care therapy for immunosuppression in liver transplantation, but they can contribute to adverse reactions, including impaired renal function. According to Novartis, Zortress works by binding to the mTOR protein and acts synergistically with CNIs, thereby offering an opportunity to lower CNI exposure.

Everolimus is one of the most extensively studied immunosuppressant agents in solid organ transplantation. Under the trade name Certican, it is approved in more than 90 countries to prevent organ rejection for renal and heart transplant patients, and it is approved in the E.U. and other countries to prevent organ rejection for liver transplant patients.

In the U.S., under the trade name Zortress, the drug is already approved for the prophylaxis of organ rejection in adult patients at low-to-moderate immunologic risk who are receiving a kidney transplant.

Source: Novartis; February 15, 2013.

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