New type 2 diabetes drug Jentadueto XR receives FDA approval

A type 2 diabetes drug called Jentadueto XR has been approved by the US Food and Drug Administration (FDA).
Jentadueto XR, developed by Boehringer Ingelheim and Eli Lilly &Co., is a new extended release form of the combination medication Jentadueto, which was approved by the FDA and the European Medicines Association (EMA) in 2012.
Jentadueto XR combines Tradjenta (linagliptin), which stimulates insulin production after meals, and extended release metformin hydrochloride.
This new XR versio, which is derived from ‘extended release’, leads to milder side effects and is recommended for people who struggle to cope with standard metformin. Some patients can experience digestive problems up to a few weeks after taking metformin.
The approval from the FDA follows trials that found Jentadueto XR to be safe and effective based on “adequate and well-controlled studies of linagliptin and metformin co-administered in patients with type 2 diabetes inadequately controlled on diet and exercise”.
The drug is suitable for patients who are treated individually with metformin and linaglipti, and should be used as part of a management treatment that includes diet and exercise.
Paul Fonteyne, CEO of Boehringer, said: “Adults with type 2 diabetes are often required to take more than one medication to manage their condition, including some that have to be taken multiple times a day.
“Jentadueto XR, the first extended-release therapy to emerge from our alliance with Lilly, offers adults with type 2 diabetes the convenience of a combination pill taken once a day to help lower blood sugar levels.”
Jentadueto XR should not be used to treat type 1 diabetes nor diabetic ketoacidosis (DKA), and carries a boxed warning of a rare but serious complication called lactic acidosis.
There is currently no word on whether the EMA is set to approve Jentadueto XR, but it is possible following its swift recommendation of the original Jentadueto in 2012 after it had been approved by the FDA.