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.
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