Amgen Seeks FDA Approval for Hyperparathyroidism Drug

Amgen is seeking FDA approval for etelcalcetide — the first calcimimetic agent for secondary hyperparathyroidism in patients with chronic kidney disease that can be administered intravenously at the end of a dialysis session.

The drug — administered three times a week — binds to and activates the calcium-sensing receptor on the parathyroid gland, decreasing secretion of parathyroid hormone (PTH) and helping to maintain healthy calcium and phosphorus levels.

The NDA submission includes data from three Phase 3 studies comparing etelcalcetide with Amgen’s Sensipar (cinacalcet), all of which met the primary endpoint of reducing PTH by at least 30 percent. Sensipar was the first calcimimetic approved by the FDA for this indication. — Kellen Owings