Sandoz's NEORAL® Cleared For Marketing by the FDA for the Prevention of Organ Rejection
- Considered Major Advance for Organ Transplantation Patients -
East Hanover, N.J. --July 17, 1995
Sandoz Pharmaceuticals Corporation announced today a significant step forward in the prevention of organ rejection following transplantation. The U.S. Food and Drug Administration has cleared for marketing NEORAL. Soft Gelatin Capsules (cyclosporine capsules for microemulsion) and NEORAL. Oral Solution (cyclosporine oral solution for microemulsion) for the prevention of organ rejection in kidney, liver and heart transplants.
NEORAL is a new formulation of cyclosporine based on microemulsion technology, designed to provide increased and more reliable absorption of the medication. These features represent improvements over Sandimmune. (cyclosporine USP), the "gold standard" of immunosuppressant therapy.
"Sandimmune made organ transplantation a truly viable medical procedure," said Alan Hull, M.D., President of the National Kidney Foundation. "There are literally thousands of people alive today who would not be here if it were not for this medication and Sandoz's commitment to transplant medicine. With the introduction of NEORAL, Sandoz has introduced a new standard in transplantation. Greater bioavailability and the more consistent drug levels offers the promise of better and easier management of all transplant patients." It is important to note that NEORAL and Sandimmune are not bioequivalent and cannot be used interchangeably without physician supervision. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe NEORAL and/or Sandimmune.
As part of the company's ongoing commitment to the transplant community, Sandoz will set an average wholesale price for NEORAL that is at parity to Sandimmune, making a superior product available at no increase in cost.
Moreover, due to the increased bioavailability of NEORAL, many patients may require lower dosages of NEORAL compared to Sandimmune. In a clinical study conducted in Germany, dosages for patients converting from Sandimmune to NEORAL were reduced by 13.4 percent. Although patients beginning or converting to NEORAL therapy will be prescribed dosages of NEORAL equal to those of Sandimmune, many patients' dosages will be titrated downward. Therefore, the cost savings to patients and the health care system are likely to be significant.
Importance of Absorption
Adequate and reliable absorption of cyclosporine is of critical importance; just the right amount of drug must reach its site of action on a consistent basis. Too much drug might cause side effects; too little drug might result in organ rejection. The absorption of Sandimmune is highly variable and does not always provide appropriate therapeutic levels. NEORAL was specifically designed to overcome this problem.
Approximately half of transplant patients are considered "poor absorbers" of cyclosporine when given as Sandimmune. Diabetics, African-Americans, young children and new liver transplant recipients are often described as poor absorbers, although any patient may absorb Sandimmune poorly. Even when it appears that cyclosporine is well absorbed in other patients, cyclosporine levels can fluctuate, posing a risk of graft rejection or drug toxicity. NEORAL is well absorbed in nearly all patients; therefore, almost all patients may benefit from the new formulation. "NEORAL is an important advance especially for patients who have poor or inconsistent absorption of cyclosporine from Sandimmune," said Russell Wiesner, M.D., Medical Director, Liver Transplantation, Mayo Clinic and Mayo Foundation. "In addition, the benefits should also apply to patients who adequately absorb Sandimmune because they too experience fluctuating levels of cyclosporine."
Extensive clinical trials are underway to further define the many benefits this unique product offers.
Clinical studies show that the principal adverse effects of NEORAL are similar to those of Sandimmune, including possible renal dysfunction, tremor, hirsutism, hypertension and gum hyperplasia.
Sandoz and Organ Transplantation
Sandoz revolutionized organ transplantation a dozen years ago with the introduction of Sandimmune, a drug that dramatically increased the odds of organ survival in transplant patients. Now, there are approximately 18,000 transplants performed annually in the United States.
The U.S. Food and Drug Administration's (FDA) Immunosuppressant Drug Subcommittee to the Antiviral Drugs Advisory Committee voted overwhelmingly to recommend approval for NEORAL for the prevention of organ rejection in kidney, liver and heart transplants on March 31, 1995. Two New Drug applications (NDA) for NEORAL Soft Gelatin Capsules and NEORAL Oral Solution in the prevention of organ rejection were submitted to the FDA July 15, 1994, by Sandoz Pharmaceuticals Corporation.
NEORAL Soft Gelatin Capsules will be available in 25 mg and 100 mg strengths. NEORAL Oral solution will be available in 50 ml bottles. Both of the capsule strengths and the oral solution will be available in pharmacies in September of 1995.
Sandoz Pharmaceuticals Corporation is a leader in the discovery, development, manufacturing and marketing of innovative pharmaceuticals and high quality consumer health products. Particular emphasis and expertise are focused on finding new treatments or cures in the areas of immunology, oncology, neurology and dermatology. Sandoz Pharmaceuticals Corporation, located in East Hanover, New Jersey is an affiliate of Sandoz Ltd. of Basel, Switzerland.
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Please see full prescribing information for NEORAL and Sandimmune. This information is available upon request. (Call 201-503-7500)