FDA Rejects Amgen Hormonal-Imbalance Treatment

Amgen Inc. said Wednesday that government regulators have rejected its new drug application for its therapy for a hormonal imbalance common in patients on dialysis.

Shares of the drugmaker slipped 0.35% to $170.25 in after-hours trading.

Amgen said it expects to meet with the U.S. Food and Drug Administration to discuss the agency's decision sometime later this year. The company said it was reviewing the government response but didn't provide specifics.

The FDA issued the complete response letter in reply to Amgen's petition for etelcalcetide, an intravenous treatment for secondary hyperparathyroidism in patients with chronic kidney disease.

The biopharmaceutical company acquired the treatment, also known by the marketing name Parsabiv, as part of its $315 million acquisition of KAI Pharmaceuticals in July 2012.

According to Amgen, secondary hyperparathyroidism affects many of the roughly two million people globally who receive dialysis, including some 450,000 people in the U.S.

Write to Ezequiel Minaya at [e-mail]

(END) Dow Jones Newswires

August 24, 2016 19:55 ET (23:55 GMT)

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