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news.Amgen has secured approval from the European Commission (EC) for Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
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Parsabiv is a calcimimetic agent where a healthcare provider can administer it intravenously three times per week at the end of a hemodialysis session.
A calcimimetic is a drug which activates the calcium-sensing receptors on the parathyroid gland.
Parsabiv binds to and activates the calcium-sensing receptor on the parathyroid gland, resulting in reduced PTH levels.
Data from three phase 3 studies, all of which met their primary endpoints, was the basis for the EC’s approval.
The studies included two pooled placebo-controlled trials in over 1,000 patients, and a head-to-head study with cinacalcet.
Etelcalcetide was superior to cinacalcet for the secondary endpoints of proportion of patients achieving more than 30% and greater than 50% reduction in mean parathyroid hormone during the efficacy assessment phase compared with baseline.
Amgen executive vice president of research and development Sean Harper said: "Treatment adherence can be a challenge with any oral medicine.
"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."
The EC approval provides Amgen with centralized marketing authorization along with unified labeling across European Union members.
Members of European Economic, Iceland, Liechtenstein, and Norway are anticipated to take corresponding decisions, relative to EC decision.