THOUSAND OAKS (dpa-AFX) - Amgen Inc. (AMGN) said Monday that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, receiving hemodialysis, met its primary and all secondary endpoints.
The primary endpoint was the proportion of patients with > 30% reduction from baseline in parathyroid hormone levels during an Efficacy Assessment Phase defined as the period between weeks 20 and 27.
The results follow the recent announcement of positive data from a prior placebo-controlled Phase 3 study of AMG 416 which was similar in design and size.
'The results from this second Phase 3 study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism,' said Sean Harper, executive vice president of Research and Development at Amgen. 'Despite the variety of options available for the treatment of this disease, an unmet need remains for an intravenous therapy that can be administered along with hemodialysis. We look forward to sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year.'
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