The Food and Drug Administration rejected Amgen's new drug intended to treat hormonal imbalances that commonly occur in patients on dialysis, reports The Wall Street Journal.
Etelcalcetide, also known as Parsabiv, is an intravenous treatment for secondary hyperparathyroidism in patients with chronic kidney disease, according to the report.
Thousand Oaks, Calif.-based Amgen gained rights to the drug through its $315 million acquisition of KAI Pharmaceuticals in July 2012.
While Amgen did not provide specific reasons why the FDA did not approve its drug application, the drugmaker said it plans to meet with the agency to discuss the decision later this year.
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