Jan. 25, 2013
/PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Pharmaceuticals
, 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
, president, Takeda Pharmaceuticals
, 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.