Takeda to Revise Timing of Alogliptin and Alogliptin/ACTOS MAA Filing in Europe
Takeda Pharmaceutical Company Limited ("Takeda") has reviewed the development strategy for the Marketing Authorization Applications (MAAs) for its investigational compounds, alogliptin and alogliptin/ACTOS (generic name: pioglitazone HCl), in Europe, and accordingly, has initiated an additional long-term clinical study for alogliptin.
The additional two-year study is to evaluate the efficacy and safety of alogliptin compared to glipizide when used in combination with metformin in targeted number of almost 2,500 subjects with type 2 diabetes, whose blood sugar level is inadequately controlled with metformin.
With the results of this additional study, Takeda expects that the MAA submissions will be made with a more robust data set necessary to ensure its approval, and as a result, the target timing of MAAs is revised from the original plan of mid-2009 to 2012.
Alogliptin, which was discovered by Takedaâs wholly owned U.S. subsidiary, Takeda San Diego, Inc. is a dipeptidyl peptidase IV (DPP-4) inhibitor for the treatment of type 2 diabetes. By providing complementary mechanisms of action, alogliptin/ACTOS targets the core defects of type 2 diabetes â insulin resistance (when the body does not efficiently use the insulin it produces) and insulin deficiency (when the body does not produce enough insulin).
Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda (TSE:4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.