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Amgen (AMGN) Announces Two AMG 416 Phase 3s Met Primary Endpoints in CKD

May 29, 2015 6:47 AM UTC

Amgen (Nasdaq: AMGN) announced pooled data from two pivotal Phase 3, global, randomized, placebo-controlled trials evaluating AMG 416, a novel calcimimetic, for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis. Both studies met the primary endpoint, demonstrating that a greater proportion of patients in the AMG 416 groups achieved a greater than 30 percent reduction in parathyroid hormone (PTH) during the Efficacy Assessment Phase compared with placebo. The data were presented today at the 52nd ERA-EDTA Congress in London.

"Secondary hyperparathyroidism is a complex and challenging condition... More