FDA Rejects Amgen Hormonal-Imbalance Treatment
August 24 2016 - 8:10PM
Dow Jones News
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 ezequiel.minaya@wsj.com
(END) Dow Jones Newswires
August 24, 2016 19:55 ET (23:55 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
Amgen (NASDAQ:AMGN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Amgen (NASDAQ:AMGN)
Historical Stock Chart
From Sep 2023 to Sep 2024