EAST HANOVER, N.J., Nov. 14 /PRNewswire/ — Novartis Pharmaceuticals Corporation announced today that it has submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration for SIMULECT(TM) (basiliximab), a monoclonal antibody to prevent acute rejection episodes following renal transplantation. Despite currently effective therapies, a significant proportion of organ transplant recipients still experience acute rejection episodes (periods of time where the body’s immune system begins to reject a transplant), which may require aggressive treatment and/or hospitalization to prevent organ loss.
SIMULECT is a selective, high-affinity antibody, that works by blocking the receptor for a protein (interleukin-2) that stimulates the proliferation of white blood cells (T-lymphocytes), which play a key role in transplant organ rejection. The mode of action of SIMULECT compliments that of NEORAL(R) (cyclosporine for microemulsion), the worldwide market leader for the prevention of organ rejection in kidney, liver end heart transplants.
Pooled results of the clinical trials showed a two-dose regimen of SIMULECT (20 mg per dose of SIMULECT on day zero and day four) following a renal transplant proportionally reduced the incidence of biopsy-proven acute rejection by thirty-one percent (45% with placebo; 31% incidence with SIMULECT, p<.001) during the first six months post transplant. A follow-up of these patients showed that this effect was maintained for at least twelve months.
“The study results found that in the SIMULECT patient groups, there were no reports of cytokine release syndrome (a potentially serious reaction owing to release of cell messenger molecules) or myelosuppression (lowering of the blood cell count). The rates for malignancies, reported infections, and serious infections were similar in the SIMULECT and placebo treatment groups. Both the acute tolerability and 12-month adverse event profiles were also comparable in the SIMULECT and placebo treatment groups during these two studies.
“The filing of SIMULECT represents an important development in transplantation therapy. SIMULECT underscores our ongoing commitment to developing novel immunosuppressant therapies with complimentary mechanisms of action that enhance patient outcomes and quality of life,” said Anthony Venditti, Vice President of Transplantation, Tissue Engineering and Immunology for Novartis Pharmaceuticals Corporation. “As part of this commitment, Novartis is exploring other transplant indications for SIMULECT.”
The FDA submission included data from two phase III clinical trials conducted in the U.S. and Europe involving a total of 729 renal transplant recipients. The studies tested the efficacy and tolerability of SIMULECT, used concomitantly with NEORAL (cyclosporine for microemulsion) and corticosteroids, in reducing acute rejection episodes. The randomized, double-blind, placebo-controlled trials studied a broad base of recipients undergoing first cadaveric or living-related transplantation. Utilizing than same clinical trial data, SIMULECT was also submitted to the European Medicines Evaluation Agency on October 7th. Investigators from one trial published in The Lancet, said, “One of the key features associated with treatment with basiliximab is the short term and straightforward dosing regimen.”