FDA approves Amgen's Parsabiv

FDA approved Parsabiv etelcalcetide from Amgen Inc. (NASDAQ:AMGN) to treat secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis. Amgen spokesperson Kristen Davis said the company would announce pricing when the drug launches, which is expected "shortly."

Amgen received a complete response letter from FDA in August 2016 for the therapy, but did not disclose the agency's concerns. EMA approved the drug in November (see BioCentury Extra, Aug. 24, 2016)...