Takeda announced that the FDA has approved Nesina (alogliptin), Oseni (alogliptin and Pioglitazone), and Kazano (alogliptin and metformin HCl) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.
Nesina is a dipeptidyl peptidase-4 inhibitor (DPP-4i) that slows the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). Oseni, which combines alogliptin with pioglitazone, is the first to include both a DPP-4i and a thiazolidinedione (TZD) in a single tablet. Kazano combines alogliptin with metformin HCl, a biguanide also indicated for the treatment of diabetes.
The approval was based on worldwide placebo-and active-controlled clinical trials of Nesina involving >13,000 patients. The safety and efficacy of Nesina was evaluated as a once-daily monotherapy and in combination with other anti-diabetic medications, including biguanides, TZDs, insulin, and sulfonylureas. Studies showed that Nesina demonstrated clinically and statistically significant improvements in hemoglobin A1c compared to placebo.
Takeda plans to launch Nesina (6.25mg, 12.5mg, 25mg tablets), Oseni (25mg/15mg, 25mg/30mg, 25mg/45mg, 12.5mg/15mg, 12.5mg/30mg, and 12.5mg/45mg tablets), and Kazano (12.5mg/500mg and 12.5mg/1000mg tablets) in the summer of 2013.
For more information call (877) 825-3327 or visit www.takeda.us