Amgen Files for U.S. Approval of Therapy for Dialysis Patients
August 25 2015 - 9:40AM
Dow Jones News
Amgen Inc. said it submitted a new drug application to the U.S.
Food and Drug Administration for its intravenous treatment for
secondary hyperparathyroidism in patients with chronic kidney
disease.
The therapy aims to treat a hormonal imbalance common in
patients who are on dialysis. The biopharmaceutical company
acquired the treatment—called etelcalcetide—as part of its $315
million acquisition of KAI Pharmaceuticals in July 2012.
In a news release Tuesday, the Thousand Oaks, Calif., company
said that if approved, the treatment—formerly known as AMG
416—would be the first of its kind that can be administered
intravenously at the end of the dialysis session.
Etelcalcetide showed positive results in three late-stage
studies, including a trial that compared the treatment with Amgen's
Sensipar oral treatment for the disease.
According to Amgen, secondary hyperparathyroidism affects many
of the roughly two million people globally who receive dialysis,
including 450,000 people in the U.S.
Amgen has continued to showcase its drug pipeline, which
includes the potential for a number of product launches this year,
including a cholesterol-lowering PCSK9 drug that analysts expect to
be a blockbuster. Like other big drug makers, Amgen needs to bring
new treatments to market as older ones face the threat of low-price
competition.
Amgen earlier this year received approval from European
regulators for cholesterol-lowering drug Repatha and is expecting a
decision from the FDA on that drug this week. In June, an FDA
advisory panel recommended that the agency approve Repatha, part of
a class of drugs known as PCSK9 agents. The FDA often follows the
recommendations of its advisory panels, but it isn't required to do
so.
Write to Tess Stynes at tess.stynes@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
August 25, 2015 09:25 ET (13:25 GMT)
Copyright (c) 2015 Dow Jones & Company, Inc.
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