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Amgen files calcitonin NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Amgen submits its first-in-class oral calcimimetic agent, cinacalcet, for the treatment of secondary hyperparathyroidism associated with chronic kidney disease, the firm announces Sept. 8. Cinacalcet modulates the calcium-sensing receptor on the parathyroid gland. The NDA is "based upon the successful completion of Phase III studies"; data will be presented at the American Society of Nephrology annual meeting in November. Cinacalcet is the first small-molecule therapeutic for the biotech firm...
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