FDA approves Takeda’s NESINA, OSENI and KAZANO for treatment of type 2 diabetes

Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NESINA (alogliptin) and the fixed-dose combination (FDC) therapies 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.

"Takeda is pleased with the FDA approval of NESINA, OSENI and KAZANO for the treatment of type 2 diabetes, a therapeutic category in which we have more than twenty years of clinical and patient experience," said Douglas Cole , president, Takeda Pharmaceuticals U.S.A., Inc. "Millions of people are affected by diabetes and, as a leader in the diabetes arena, Takeda is dedicated to working to advance patient care and helping to meet the needs of this growing patient population."

NESINA is a dipeptidyl peptidase-4 inhibitor (DPP-4i) that is designed to slow 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 product in the U.S. to include both a DPP-4i and a thiazolidinedione (TZD) in a single tablet. KAZANO combines alogliptin with metformin HCl, a widely used anti-diabetes medication, in a single tablet.

The most common adverse events (greater than or equal to 4%) reported with NESINA include nasopharyngitis, headache and upper respiratory tract infection. With regard to OSENI, common adverse events (greater than or equal to 4%) reported include nasopharyngitis, back pain and upper respiratory tract infection. Common adverse events (greater than or equal to 4%) reported with KAZANO include upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain and urinary tract infection.

Takeda is committed to providing type 2 diabetes patients with treatment options that help address their needs, and is planning to commercially launch NESINA, OSENI and KAZANO in the summer of 2013.

Takeda's consolidated financial statements for the 2012 fiscal year will not be impacted by the FDA approvals.