FDA rejects Amgen's Parsabiv

Amgen Inc. (NASDAQ:AMGN) received an FDA complete response letter for Parsabiv etelcalcetide to treat secondary hyperparathyroidism in hemodialysis-dependent adults with chronic kidney disease.

Spokesperson Kristen Davis declined to disclose FDA's concerns with the NDA for Parsabiv, a peptide calcimimetic that acts on the parathyroid gland to reduce production of parathyroid hormone (PTH). The company said it hopes to meet with FDA this year to discuss the letter. ...