Type 2 Diabetes Treatment Invokamet XR Awaits FDA Action

Janssen Research and Development LLC has submitted a new drug application to the FDA for canagliflozin and metformin hydrochloride extended release (Invokamet XR).

Janssen Research and Development LLC has submitted a new drug application to the FDA for canagliflozin and metformin hydrochloride extended release (Invokamet XR).

The once-daily 2 tablets are designed to treat type 2 diabetes in adults as an adjunctive treatment to diet and exercise to improve glycemic 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,” said James List, global therapeutic area head of Cardiovascular and Metabolism at Janssen, in a press release. “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.”

Invokamet, the first fixed-dose combination tablet to combine canagliflozin and immediate release metformin hydrochloride, received approval from the FDA back in 2014.

Adverse effects associated with the treatment include lactic acidosis and dehydration.