The FINANCIAL — Takeda Pharmaceutical Company Limited announced on September 28 that it has submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan for the fixed-dose combination of Nesina (generic name: alogliptin benzoate) and metformin hydrochloride (hereafter “metformin”) for the treatment of type 2 diabetes. Type 2 diabetes is the most common form of diabetes, affecting millions of people globally. Worldwide, there are 382 million people living with diabetes, and the International Diabetes Federation (IDF) predicts there will be 592 million people with the condition by 2035.
Nesina is a once-daily dipeptidyl peptidase-IV (DPP-4) inhibitor. It controls blood glucose levels by selectively inhibiting DPP-4, an enzyme that causes the inactivation of glucagon-like peptide-1 and glucagon-dependent insulinotropic polypeptide, incretin hormones* that play an important role in blood glucose regulation. The inhibition of DPP-4 increases insulin secretion depending on blood glucose concentration, thereby controlling blood glucose levels. Metformin is a widely used as biguanide that controls blood glucose level primarily by inhibition of glucose production in the liver, according to Takeda.
Prior to filing this application, Takeda had conducted a phase III multicenter, randomized, double-blind comparative trial in Japan involving a total of 374 type 2 diabetic patients with inadequate control with Nesina alone, where the combination of Nesina and metformin as once-daily dosing was evaluated for its efficacy and safety. In this study, the combination of Nesina and metformin as once-daily dosing was shown to be superior to Nesina alone in regard to the changes in HbA1c from baseline (primary endpoint) and to offer a comparable safety and tolerability profile to Nesina alone. The fixed dose combination of Nesina and metformin is the only combination of a DPP-4 inhibitor and metformin to offer once-daily dosing.
Toshio Heya, head of Takeda Development Center Japan, said “diabetes is a complex and highly progressive disease, and many patients fail to meet glycemic targets despite the variety of treatment options available. Flexibility of treatment based on the individual’s disease progression is the cornerstone of successful management of type 2 diabetes.
The introduction of Takeda’s multiple Type 2 diabetes therapies enables health care professionals to tailor a more customized treatment approach to meet their patients’ individual needs.”