New FDA Approvals

These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):

Cinacalcet (Sensipar) by Amgen. The FDA has approved cinacalcet (Sensipar), a drug to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, and hypercalcemia in patients with parathyroid cancer.

Cinacalcet is the first drug in the class of calcimimetics to be approved by the FDA. Treatment with cinacalcet lowers serum levels of parathyroid hormone as well as the calcium x phosphorus ion product.

In three six-month cinacalcet clinical trials of more than 1,000 patients with chronic kidney disease receiving dialysis, the most commonly reported side effects were nausea and vomiting, which occurred in 31% and 27%, respectively, of cinacalcet-treated patients, compared with 19% and 15%, respectively, of patients who received placebo. Treatment of patients with chronic kidney disease with cinacalcet also was associated with the development of low serum calcium levels in a significant number of patients. Frequent monitoring of patients’ calcium levels is therefore recommended in the cinacalcet labeling.