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FDA Approves Boehringer Ingelheim and Eli Lilly’s Tradjenta

Earlier this month, the FDA approved the once-daily oral drug Tradjenta (Boehringer Ingelheim and Eli Lilly’s linagliptin) for type 2 diabetes. Tradjenta belongs to the DPP-4 inhibitor drug class, which also includes Merck’s Januvia, Bristol-Myers Squibb/AstraZeneca’s Onglyza, Novartis’ Galvus, and Takeda’s Nesina (the last two of which are currently available only outside the United States). Notably, doctors may perceive Tradjenta as an easier recommendation for people with kidney disease, since it is not primarily cleared by the kidneys as are other members of the drug class. The implication? One dose for everyone, unlike other DPP-4 inhibitors that have more than one dose depending on renal (kidney) health, which means that doctors must periodically test renal function in order to know the proper dosage.

Some background: DPP-4 inhibitors allow the gut hormone GLP-1 to remain longer in the body, which improves glycemic control with a positive side effect profile: less hypoglycemia and less weight gain than many other classes of oral drugs. In the past few years, DPP-4 inhibitors have become increasingly popular, probably because they are once-a-day tablets and have infrequent side effects (e.g., headache, the common cold) and an ever more positive safety profile. While there have been infrequent reports of pancreatitis associated with DPP-4 inhibitors, we increasingly hear the growing safety database associated with the class as a major benefit. Some DPP-4 inhibitors are also available in combination pills with other diabetes drugs, such as metformin (Janumet for Januvia, Kombiglyze for Onglyza, and Eucreas for Galvus), and other combinations are in development – such compounds have even more impressive efficacy data than the non-combo pills, all of which tend to reduce A1c between 0.5% and 0.8%. It is impossible to compare these, however, as there are no head-to-head trials to date among the agents.

Tradjenta is the first diabetes drug to be sold and marketed by Boehringer Ingelheim. The company has another closely-watched diabetes drug in development, an SGLT-2 inhibitor, a new type of oral medications that cause blood glucose to be filtered by the kidneys and lost in the urine (see our Learning Curve in diaTribe #8). Boehringer Ingelheim is studying the use of Tradjenta in combination with its SGLT-2 inhibitor, which would be a new type of combination treatment. We suspect that Bristol-Myers Squibb/AstraZeneca will likely try the same thing with Onglyza and their SGLT-2 inhibitor (called dapagliflozin). DPP-4 inhibitor/SGLT-2 inhibitor combination therapy would likely lower glucose with relatively few side effects and the potential for more significant weight loss.  --VW

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