Regulators in the USA have given the green light to Novartis’ Zortress to prevent the rejection of kidney transplants in adults.

The US Food and Drug Administration has approved Zortress (everolimus), oral tablets for the prevention of rejection of kidney transplants in patients at low-to-moderate immunologic risk. The drug can be given in combination with reduced doses of the calcineurin inhibitor cyclosporine, as well as basiliximab and corticosteroids.

Sold under the brand name Certican, everolimus is already “an established part of the immunosuppressive regimen for transplant patients in more than 70 countries outside the USA,” Novartis noted. This latest approval is based on results from “the largest single Phase III registration study ever conducted in kidney transplant recipients”, the firm added.

In that study, Zortress prevented acute organ rejection and preserved kidney function while allowing, on average, 60% lower doses of cyclosporine to be used compared with the control regimen of mycophenolic acid with full-dose cyclosporine and corticosteroids. Use of everolimus led to a reduction in calcineurin inhibitors-associated side effects (eg kidney injury and infections) while maintaining good efficacy.

Zortress has been approved in the USA with a risk evaluation and mitigation strategy, Novartis said, noting that in 2009, 16,800 kidney transplants were performed in the USA, and an estimated 4,500 candidates died while awaiting organ donation. As of March this year, there were more than 83,000 patients on the waiting list in the USA.

Everolimus is also available in different dosage strengths as Afinitor for the treatment of advanced renal cell carcinoma after failure of treatment with Pfizer’s Sutent (sunitinib) or Bayer’s Nexavar (sorafenib). Afinitor was approved in the USA a year ago.