Amgen (AMGN) Reports EC Approval for Parsabiv to Treat sHPT in Adults with CKD

November 11, 2016 4:01 PM EST

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Amgen (NASDAQ: AMGN) today announced that the European Commission (EC) has granted marketing authorization for Parsabiv™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Parsabiv is the first calcimimetic agent that can be administered intravenously by a healthcare provider three times a week at the end of a hemodialysis session.

"Keeping relevant lab values in recommended target ranges is an important part of managing sHPT, a chronic and complex disease with an already complicated medication regimen for many patients," said John Cunningham, M.D., professor of nephrology at University College London Medical School. "Treatment failures are quite common and Parsabiv provides a new tool that should give physicians more confidence that patients are getting the medication they need to treat their sHPT."

The EC approved Parsabiv based on three Phase 3 studies, all of which met their primary endpoints, including two pooled placebo-controlled trials in more than 1,000 patients, and a head-to-head study with cinacalcet. Additionally, etelcalcetide was superior to cinacalcet for the secondary endpoints of proportion of patients achieving greater than 30 percent and greater than 50 percent reduction in mean parathyroid hormone (PTH) during the Efficacy Assessment Phase (EAP) compared with baseline.

"Treatment adherence can be a challenge with any oral medicine," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "If poorly controlled, sHPT may progress and can have significant clinical consequences. With Parsabiv, we can put the delivery of the therapy in the hands of the healthcare provider and help ensure that these patients receive this important treatment as part of their dialysis session three times a week."

Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.

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