Takeda Submits DPP-4 Inhibitor Alogliptin and Combination Alogliptin/Actos and Alogliptin/Metformin Pill for Approval in the US

Recently, we learned that the Japan-based pharmaceutical company Takeda has submitted its type 2 diabetes therapy alogliptin for approval in the US. The therapy has been available in Japan since 2010 under the brand name Nesina. Alogliptin belongs to a class of drugs called DPP-4 inhibitors, which help the body secrete insulin only when blood glucose levels are high. Currently, there are three approved DPP-4 inhibitors in the US –Januvia (sitagliptin), Onglyza (saxagliptin), and Tradjenta (linagliptin). What distinguishes alogliptin from these other therapies, however, is that it may also become available in combination with the type 2 diabetes therapy Actos (pioglitazone) in a single pill. Actos, part of the class of medications known as TZDs, helps improve blood glucose control by increasing the body’s sensitivity to insulin. Thus, by targeting both insulin secretion (via a DPP-4 inhibitor) and insulin sensitivity (via a TZD), a combination alogliptin/Actos pill could form a very powerful (and convenient) therapy for people with type 2 diabetes. The FDA is expected to make a decision on whether or not to approve both alogliptin and the combination pill by April 25, 2012. We note that some studies have associated use of Actos for more than one year with bladder cancer. In response, the FDA recently updated the medication’s label and will be looking for further clarity as more extensive trial data becomes available. For more information, please see NewNowNext in diaTribe #34. In the last week of November, Takeda also submitted a combination alogliptin/metformin pill for approval in the US. For more information on other combination DPP-4 inhibtor/metformin pills, please see the NewNowNext in diaTribe #28. –BK