FDA approves Zortress to prevent liver transplant rejection

The FDA recently approved mTOR inhibitor Zortress for the prevention of organ rejection in adult recipients of a liver transplant, according to a press release.

Zortress (everolimus, Novartis Pharmaceuticals) is the first immunosuppressant in more than 10 years and the first mTOR inhibitor to receive FDA approval for use following liver transplantation, Novartis said. The drug previously had been approved in the United States for therapy in kidney transplant recipients.

According to the release, this approval follows the results of a phase 3, multicenter, open-label, study involving 719 liver transplant recipients randomly assigned 30 days after transplant either standard tacrolimus therapy or a reduced dose of tacrolimus in addition to 3 ng/mL to 10 ng/mL Zortress twice daily for 12 months. Therapy with Zortress maintained similar efficacy while also resulting in improved renal function compared with tacrolimus treatment alone.

Commonly reported adverse events after liver transplant included diarrhea, headache, hypertension, nausea, fever, abdominal pain, leukopenia and peripheral edema. Potential serious events associated with Zortress included malignancies, infections and hypersensitivity reactions.

“While prevention of acute organ rejection is a key priority for physicians following liver transplantation, managing other health risks, including impaired renal function associated with calcineurin inhibitor treatment, is also critical,” John Fung, MD, PhD, director of the Transplantation Center at the Cleveland Clinic Foundation, said in the release. “With the approval of Zortress … we have a new treatment option that has the potential to address the unmet medical need for maintaining renal function without compromising acute rejection rates — and that’s important for patients and physicians.”