Janssen seeks FDA approval for combination type 2 diabetes treatment

Janssen Research & Development submitted an application to the Food and Drug Administration (FDA) Friday for the approval of Invokamet as an adjunctive treatment in adults with type 2 diabetes.

Diabetes affects approximately 29 million individuals in the United States and more than 300 million around the world with the majority of cases falling into the type 2 category. The chronic condition inhibits the body's ability to regulate glucose that can result in serious complications, such as heart disease, kidney failure and amputations of lower limbs.

Invokamet contains doses of two prescription medicines: canagliflozin and metformin hydrochloride. The first is the nation's most-prescribed non-insulin type 2 diabetes medicine and the latter is recommended as initial treatment for type 2 diabetes. The combination tablet is intended to be used along with diet and exercise to improve blood sugar control.

"This submission to the FDA is evidence of Janssen's continued commitment to bringing forth new treatment options for people with type 2 diabetes," James List, global therapeutic area head of cardiovascular and metabolism at Janssen, said. "We look forward to working with the FDA to bring this combination therapy to adult patients with type 2 diabetes in need of new options."