CHMP Issues Positive Opinion for Parsabiv to Treat Hyperparathyroidism in CDK Patients on Hemodialysis

CHMP Issues Positive Opinion for Parsabiv to Treat Hyperparathyroidism in CDK Patients on Hemodialysis

Amgen has announced that the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Union’s medical regulatory agency, has issued a positive opinion on the marketing application for Parasabiv (etelcalcetide), recommending its approval as a treatment of secondary hyperparathyroidism (sHPT) in adults with chronic kidney disease (CKD) on hemodialysis.

Patients on dialysis can be affected by sHPT, a chronic condition that causes the parathyroid glands to secrete parathyroid hormone (PTH) in excess, in response to impaired renal function and compromised mineral metabolism. High levels of PTH can lead to an increased release of calcium and phosphorus from the bones.

In Europe, the prevalence of sHPT among dialysis patients ranges from 30% to 49%, but because it is often silent and asymptomatic in initial stages, sHPT is frequently underdiagnosed and undertreated.

Parsabiv is a calcimimetic agent currently being developed for intravenous (IV) administration at the end of a hemodialysis session. Calcimimetics mimic the action of calcium by activating the calcium-sensing receptors of the parathyroid gland. If approved, Parsabiv will be the first intravenous calcimimetic agent that can be administered three times a week following a hemodialysis session.

“We are pleased to receive a positive CHMP opinion for Parsabiv, which has demonstrated strong efficacy in clinical trials and could help fill an unmet need in the delivery of this important therapy,” Sean E. Harper, M.D., executive vice president of Amgen’s Research & Development, said in a press release. “Secondary hyperparathyroidism is a disease that affects many patients with advanced chronic kidney disease.”

The application included data from three Phase 3 studies, all of which met their primary endpoints. Two were pooled placebo-controlled trials in over 1,000 patients, and the third a head-to-head trial evaluating the comparable effectiveness of Parsabiv to Mimpara (cinacalcet; brand name in U.S. is Sensipar, also marketed by Amgen) (NCT01896232).

Cinacalcet is the first oral calcimimetic agent approved by the European Medicines Agency (EMA) for the treatment of sHPT in CKD patients on dialysis.  Cincalcet binds to the calcium-sensing receptor, resulting in a drop in PTH levels by inhibiting PTH synthesis and secretion.

The European Commission will now review CHMP’s positive opinion to decide whether or not to approve Parsabiv in the European Union. If approved, a centralized marketing authorization will be granted in the 28 EU member states, as well as in Norway, Iceland and Lichenstein.

Amgen recently announced that it was reviewing a “complete response letter” from the U.S. Food and Drug Administration regarding its application for U.S. approval of the treatment.

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