Amgen Inc. (AMGN) announced encouraging results from a phase III study evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis.
The randomized, active-controlled, double-blind, double-dummy head-to-head phase III study compared the efficacy and safety of AMG 416 with Sensipar (cinacalcet) for the treatment of SHPT in patients with CKD receiving hemodialysis.
The study met the primary endpoint as AMG 416 showed non-inferiority to Sensipar, measured as the achievement of a greater than 30% reduction from baseline in mean pre-dialysis serum intact parathyroid hormone (PTH) levels during the Efficacy Assessment Phase (EAP). EAP is defined as the period between weeks 20 and 27.
Additionally, it was found that AMG 416 was statistically and significantly superior to Sensipar in the secondary endpoints of the proportion of patients achieving greater than 50% and greater than 30% PTH reduction from baseline during the EAP.
Additionally, no difference between the treatment arms in the mean number of days of vomiting or nausea per week was noticed in the first eight weeks.
Secondary hyperparathyroidism is often progressive in patients suffering from CKD. According to the press release issued by Amgen, secondary hyperparathyroidism affects a large number of the approximately two million dialysis-dependent patients worldwide.
We are pleased with the encouraging data on AMG 416. We expect investors to positively react to the news.
Amgen carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include BioMarin Pharmaceutical Inc. (BMRN), Cytokinetics, Inc (CYTK) and Medivation, Inc. (MDVN). While BioMarin and Cytokinetics carry a Zacks Rank #1 (Strong Buy), Medivation is a Zacks Rank #2 (Buy) stock.
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