FDA lifts Boxed Warning on canagliflozin drugs

Based on a US Food and Drug Administration review of new data from three clinical trials, the agency has removed the Boxed Warning about amputation risk from the diabetes medicine canagliflozin, which was developed by the Johnson & Johnson (NYSE: JNJ) unit Janssen, and is marketed under the brand names Invokana, Invokamet and Invokamet XR.

The Invokana/Invokamet franchise generated first-half 2020 sales of $1.09 billion for J&J.

The FDA required the Boxed Warning in 2017 based on its assessment that the risk of amputations was very serious in relation to the potential benefit of canagliflozin, which was initially approved to be used with diet and exercise to lower blood sugar in adults with type 2 diabetes. Subsequent FDA reviews of new clinical trial data demonstrated additional heart- and kidney-related benefits, which led to additional approved uses.