FDA approves Janssen's Invokana to reduce MACE in Type II diabetics

The Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) said FDA approved an sNDA for Invokana canagliflozin to reduce the risk of major adverse cardiovascular events (MACE) -- heart attack, stroke or death due to a CV cause -- in Type II diabetics who have established cardiovascular disease. The company said Invokana is the only oral diabetes drug approved in the indication.

The approval was based on the CANVAS Phase III and Phase IV trials, which evaluated the CV safety of Invokana in more than 10,000 Type II diabetics with established CV disease or with two or more CV risk factors (see “J&J’s Invokana Improves CV Outcomes Despite Amputation Risk”)...