Amgen’s AMG 416 meets Phase III studies’ endpoints
US biotech major Amgen (Nasdaq: AMGN) has presented positive pooled data from two pivotal Phase III, 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% 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.
Complex and challenging condition
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