Trade Resources Company News Takeda Has Received FDA Approval for Three New Type 2 Diabetes Therapies Nesina

Takeda Has Received FDA Approval for Three New Type 2 Diabetes Therapies Nesina

Takeda Pharmaceutical has received FDA approval for three new type 2 diabetes therapies Nesina (alogliptin) and fixed-dose combinations Oseni (alogliptin and pioglitazone) and Kazano (alogliptin and metformin HCl).

Takeda expects to launch the type 2 diabetes therapies as adjuncts to diet and exercise in the summer of 2013.

Takeda Pharmaceuticals USA president Douglas Cole said, "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."

Nesina dipeptidyl peptidase-4 inhibitor (DPP-4i) is designed to slow the inactivation of incretin hormones glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.

A single Oseni tablet, a combination of alogliptin with pioglitazone, includes both a DPP-4i and a thiazolidinedione.

Kazano anti-diabetes medication combines alogliptin with metformin HCl in a single tablet.

The most common adverse events reported with Nesina include nasopharyngitis, headache and upper respiratory tract infection while nasopharyngitis, back pain and upper respiratory tract infection were reported with Oseni.

Common adverse events reported with Kazano are upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain and urinary tract infection.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-approves-three-new-takeda-type-2-diabetes-therapies-280113
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FDA Approves Three New Takeda Type 2 Diabetes Therapies