Takeda re-files Nesina at the FDA for Type 2 Diabetes

Takeda has re-filed applications for Nesina (alogliptin) as a monotherapy and alogliptin plus pioglitazone at the FDA following a Complete Response Letter as the FDA requires a cardiovascular safety study to support the monotherapy application. A large-scale, placebo-controlled study called EXAMINE has enrolled around 5,400 patients and the resubmissions are supported by interim data from this study which compares alogliptin in addition to standard of care with standard of care alone in patients with Type 2 Diabetes and acute coronary syndrome. Full results from the trial are expected in 2014.