Sensipar approved -- first-in-class treatment for secondary hyperparathyroidism in dialysis patients

Sensipar approved -- first-in-class treatment for secondary hyperparathyroidism in dialysis patients

THOUSAND OAKS, CALIF., March 8, 2004 -- Amgen Inc. announced that the FDA has approved Sensipar (cinacalcet HCl), following a priority review.

Sensipar, an innovative, first-in-class oral calcimimetic, is indicated for the treatment of secondary hyperparathyroidism (secondary HPT) in chronic kidney disease (CKD) patients on dialysis, and the treatment of elevated calcium levels (hypercalcemia) in patients with parathyroid carcinoma; and has been shown to be safe and effective. Nearly all of the more than 300,000 dialysis patients in the U.S. suffer from secondary HPT. The disease can develop early during the course of CKD and continues to progress as kidney function declines. Untreated secondary HPT is characterized by abnormal calcium and phosphorus levels and is associated with serious consequences, including cardiovascular morbidity.

Sensipar meets a significant medical need in patients with secondary HPT. "It is the only available therapy that allows practitioners to reduce parathyroid hormone (PTH) while lowering calcium-phosphorus product, which is consistent with the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (K/DOQI) clinical practice guidelines for bone metabolism and disease in chronic kidney disease," said Beth Seidenberg, M.D., chief medical officer and senior vice president of global development at Amgen.

The NKF's K/DOQI clinical practice guidelines are a response to the strong correlation between these biochemical parameters and morbidity and mortality in the CKD population.

Secondary HPT is characterized by elevations in PTH, calcium and phosphorus levels. If left untreated, patients with secondary HPT develop bone disease, bone pain and fractures, vascular and soft tissue calcifications, which are frequently associated with an increased risk of hospitalization and death.

Prior to the approval of Sensipar, the only available medical treatments for patients with secondary HPT were phosphate binders and vitamin D sterols, which may elevate calcium and/or phosphorus levels. As a consequence, treatment is frequently interrupted -- resulting in inadequate control of PTH. Sensipar provides targeted treatment of secondary HPT with its unique mechanism of action that acts directly on the calcium-sensing receptor, the primary regulator of PTH.

"With cinacalcet HCl now available, there is no question that there is a large number of patients who need this therapy right away. We have a lot of patients whose disease is very poorly controlled and in our attempt to control their disease, we are producing side effects that are completely unacceptable," said Geoffrey Block, M.D., a lead investigator for the phase 3 trials and director of clinical research at Denver Nephrologists, PC. "In the clinical trials I have done with cinacalcet HCl, I have been astounded by how well this drug can control PTH, lower calcium and lower phosphorus. Patients for the first time are achieving levels of phosphorus that they recognize will protect their health over the long term."

Sensipar provides significant improvement over traditional therapy by bringing multiple parameters into NKF's K/DOQI clinical practice guidelines recommended target range at the same time.

"Achieving the new K/DOQI guidelines has been challenging with existing therapies, and has required clinicians to make tough decisions regarding therapeutic goals," said Brian Pereira, M.D., president and chief executive officer at the New England Health Care Foundation and professor of medicine at Tufts-New England Medical Center. "Sensipar gives the nephrology community an important new tool to help dialysis patients suffering from secondary HPT to achieve all four therapeutic target goals."

For more details, and full prescribing information, visit www.amgen.com

Source: Amgen Inc.

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