Novartis statement on FDA Advisory Committee recommendation to approve everolimus for use in kidney transplantation

Gaithersburg, MD (December 7, 2009) — The Cardiovascular and Renal Drugs Advisory Committee convened by the US Food and Drug Administration (FDA) today, by a vote of 11–1, recommended that the FDA approve everolimus for the prophylaxis of acute organ rejection in de novo kidney transplant recipients. The committee recommended that a Risk Evaluation and Mitigation Strategy (REMS) be implemented for everolimus. Novartis proactively submitted a REMS to help guide physicians and patients on the use of everolimus in kidney transplantation.

The vote was based on a proposed regimen that includes an initial dose of everolimus 1.5 mg (0.75 mg twice–daily) followed by whole blood trough concentrations adjusted using therapeutic drug monitoring (TDM) to 3–8 ng/ml, in combination with basiliximab, corticosteroids, and reduced dose cyclosporine, also adjusted using TDM.

Novartis Pharmaceuticals Corporation (Novartis) is encouraged by the Advisory Committee's majority vote in support of everolimus approval. Preventing acute rejection while minimizing immunosuppressive-regimen–associated nephrotoxicity is among the biggest challenges in kidney transplantation today, and new effective treatment options are clearly needed. If approved by the FDA, everolimus will provide a meaningful alternative therapy for de novo kidney transplant recipients by effectively controlling acute rejection while reducing exposure to calcineurin inhibitors (CNIs) and CNI–associated adverse events.

The FDA generally follows the recommendations of its Advisory Committees, although it is not bound by them. Novartis will work closely with the FDA as it completes its review of the everolimus NDA.

In 2008, an estimated 16,500 kidney transplants were performed in the US and more than 4,500 kidney transplant candidates died while awaiting organ transplantation. As of October 2009, there were approximately 82,000 candidates awaiting kidney transplantation.

For more than 25 years, Novartis has been a leader in transplantation, working together with healthcare professionals to benefit transplant recipients through a wide range of initiatives. Novartis longstanding commitment to supporting the transplant community shapes the way we do our work and, ultimately, helps improve transplant outcomes now and in the future.

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Novartis Pharmaceuticals Corporation Media Relations

Maureen Byrne
NPC Communications
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Anna Frable
NPC Communications
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