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New Drug Application for Cinacalcet HCl Submitted to FDA
THOUSAND OAKS, Calif., Sept. 8 /PRNewswire-FirstCall/ -- Amgen filed a new drug application (NDA) with the U.S. Food & Drug Administration for cinacalcet HCl, a first-in-class oral calcimimetic agent, licensed from NPS Pharmaceuticals, Inc., currently being investigated for the treatment of secondary hyperparathyroidism (SHPT) associated with chronic kidney disease. The filing was based upon the successful completion of phase 3 studies, which will be presented at the American Society of Nephrology annual meeting in November.
Cinacalcet HCl is the company's first small molecule therapeutic and represents an important milestone for Amgen and furthers the company's commitment to the nephrology community. It also represents a potentially significant advance for chronic kidney disease patients diagnosed with SHPT, a common yet serious metabolic disorder where parathyroid hormone levels are elevated. Patients with this disease can suffer from bone disease, bone pain and fractures, soft tissue calcification, vascular calcification and cardiovascular complications.
Cinacalcet HCl is an oral compound with a unique mechanism of action that modulates the behavior of the calcium-sensing receptor on the parathyroid gland. By increasing sensitivity of the receptors to calcium levels in the bloodstream, cinacalcet HCl may lead to a reduction in the levels of parathyroid hormone, calcium, phosphorous and the calcium-phosphorous product. Currently, there are no therapies available that have these features.