The European Commission has granted marketing authorization for Amgen’s Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism (sHPT) in adult patients on hemodialysis. Parsabiv is the first calcimimetic agent that can be administered intravenously by a health care provider three times a week at the end of a hemodialysis session.
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.
In August, the U.S. Food and Drug Administration rejected the new drug application for Parsabiv. The FDA issued a complete response letter to Amgen, and Amgen has not disclosed the details of the letter.
“Amgen is reviewing the complete response letter, and we anticipate a post-action meeting with the FDA later this year to discuss the complete response,” according to a statement from the company. “The Complete Response Letter does not impact our regulatory submissions in other regions.”