J&J Unit Gets FDA Priority Review of Invokana in Chronic Kidney Disease
May 22 2019 - 9:51AM
Dow Jones News
By Colin Kellaher
Johnson & Johnson's (JNJ) Janssen Pharmaceutical Cos. unit
on Wednesday said the U.S. Food and Drug Administration granted
priority review to its supplemental new-drug application for the
diabetes drug Invokana in patients with chronic kidney disease.
The drug maker is seeking approval for Invokana to reduce the
risk of end-stage kidney disease, the doubling of serum creatinine,
and renal or cardiovascular death in adults with type 2 diabetes
and chronic kidney disease.
The FDA grants priority review to medicines that have the
potential to provide significant improvements in the treatment of a
serious disease, and the designation shortens the review period to
six months from the standard 10 months.
Janssen said Invokana, if approved for the new indication, would
be the first and only diabetes medicine to treat chronic kidney
disease in patients with type 2 diabetes.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 22, 2019 09:36 ET (13:36 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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