Amgen (AMGN) Affirms Receipt of Positive CHMP Opinion on Parsabiv for Secondary Hyperparathyroidism

September 16, 2016 7:36 AM EDT

Get access to the best calls on Wall Street with's Ratings Insider Elite. Get your Free Trial here.

Amgen (Nasdaq: AMGN) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of Parsabiv™ (etelcalcetide), recommending approval for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. If approved, Parsabiv will be the first calcimimetic agent that can be administered intravenously by a healthcare provider three times a week at the end of 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," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Secondary hyperparathyroidism is a disease that affects many patients with advanced chronic kidney disease, and we look forward to continuing to work with regulatory authorities to provide these patients with a novel therapy and advance the management of this complex disease."

The Marketing Authorization Application (MAA) submission for Parsabiv included data from 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 evaluating Parsabiv compared with cinacalcet.

The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralized marketing authorization with unified labeling will be granted 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.

Serious News for Serious Traders! Try Premium Free!

You May Also Be Interested In

Related Categories

Corporate News, Management Comments

Related Entities

Twitter, Dividend, Definitive Agreement

Add Your Comment