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Approvable Letter Issued for Everolimus, Treatment To Prevent Organ Rejection
EAST HANOVER, N.J., Aug. 30 /PRNewswire-FirstCall/ -- Novartis Pharma AG has received an "approvable" letter from the U.S. Food and Drug Administration (FDA) for Certican® (everolimus) in combination with Neoral® (cyclosporine, USP) MODIFIED, for the prevention of rejection episodes following heart or kidney transplantation.
The FDA has requested that Novartis provide "additional" information supporting a safe and effective dosing regimen for the combination of everolimus and cyclosporine. The FDA had previously issued an approvable letter for Certican in October 2003 with a request for additional clinical data on dosing regimens. Novartis submitted data in response to the first approvable letter in February 2004. However, the FDA still believes that additional clinical studies on dosing are necessary.
Already approved for use in Europe, Certican is a novel proliferation signal inhibitor with immunosuppressive and antiproliferative properties. It is the latest innovation in the 20-year history of Novartis leadership in transplantation medication. The new drug application to the FDA for Certican included data from one of the most extensive drug development programs conducted to date for a transplantation product.
"Everolimus has been shown in clinical trials to provide important benefits that would be of significant value to transplant patients and their health care providers," said Howard Eisen, M.D., Professor of Medicine at Temple University School of Medicine in Philadelphia.
About Neoral® (cyclosporine, USP) MODIFIED
Neoral Soft Gelatin Capsules and Oral Solution are indicated for the prevention of organ rejection in kidney, liver, and heart allogenic transplant recipients. Neoral (cyclosporine, USP) MODIFIED and Sandimmune® (cyclosporine, USP) are not bioequivalent and cannot be used interchangeably without careful monitoring of cyclosporine blood concentration. Blood level monitoring is not a replacement for clinical evaluation and routine monitoring of renal function and other laboratory tests are recommended. Dosage adjustments must be made based on individual response. The principal adverse reactions of cyclosporine therapy in transplantation are renal dysfunction, tremor, hirsutism, hypertension and gum hyperplasia. Neoral® and Sandimmune are systemic immunosuppressants and may increase the susceptibility to infection and to the development of neoplasia.
Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Neoral. At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Neoral. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.
The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. Neoral, a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients Neoral may be administered with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients.