Takeda Pharmaceutical has notified the European Medicines Agency that its mid-2009 marketing authorization applications (MAA) for alogliptin (SYR-322) and alogliptin/Actos (SYR-322-4833) have been postponed because it is initiating a long-term clinical trial for alogliptin.
The two-year study will evaluate the efficacy and safety of alogliptin compared to glipizide (Pfizer's Glucotrol) when used in combination with metformin in a targeted number of almost 2,500 subjects with type 2 diabetes whose blood sugar level is inadequately controlled with metformin. The Osaka, Japan-based Takeda is seeking to prove that alogliptin and alogliptin/Actos could be valuable new options for type 2 diabetes patients, especially when weight gain or hypoglycemia is of concern.
With the results from the additional study, Takeda said that its MAA submission will include 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 Takeda's wholly owned U.S. subsidiary, Takeda San Diego, is a dipeptidyl peptidase IV (DPP-4) inhibitor for the treatment of type 2 diabetes.