Amgen (AMGN) Affirms Receipt of Positive CHMP Opinion on Parsabiv for Secondary Hyperparathyroidism
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Amgen Receives Positive CHMP Opinion For Parsabiv™ (Etelcalcetide) For The Treatment Of Secondary Hyperparathyroidism In Adult Patients With Chronic Kidney Disease On Hemodialysis
September 16, 2016 7:34 AM EDTTHOUSAND OAKS, Calif., Sept. 16, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today 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.
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