BioCentury
ARTICLE | Clinical News

J&J planning submission for Invokana in CKD following Phase III readout

July 20, 2018 4:15 PM UTC

The Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) said Invokana canagliflozin met the primary endpoint in the Phase III CREDENCE trial to treat chronic kidney disease in patients with Type II diabetes. A J&J spokesperson told BioCentury the company plans to submit an sNDA to FDA in 1H19 to expand the indication of Invokana to treat CKD in Type II diabetics.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is already approved as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes...