Will the FDA Approve Amgen’s Drug Parsabiv Next Month?

Amgen (AMGN)
The Journal of the American Medical Association (JAMA) published findings from three Phase 3 studies of Parsabiv (etelcalcetide), an investigational intravenous calcimimetic agent in the U.S. The studies evaluated Amgen’s drug Parsabiv in more than 1,700 adults with secondary hyperparathyroidism on hemodialysis and showed that the drug produced statistically significant and clinically meaningful reductions in serum parathyroid hormone (PTH) levels, a key marker of secondary hyperparathyroidism.

Secondary hyperparathyroidism is a chronic and serious condition that is often progressive among patients with chronic kidney disease and is associated . . .

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