FDA approves three Takeda diabetes drugs

Hannah Blake

pharmaphorum

Three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes have been approved for use in the United States by the FDA.

All three of the products – Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets and Oseni (alogliptin and pioglitazone) tablets – are distributed by Japanese pharma company, Takeda.

"Controlling blood sugar levels is very important in the overall treatment and care of diabetes. Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control.”

Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.

Nesina, Kazano, and Oseni were studied as stand-alone therapies (monotherapies) and in combination with other type 2 diabetes therapies, including sulfonylureas and insulin.

Nesina was demonstrated to be safe and effective in 14 clinical trials involving about 8,500 patients with type 2 diabetes, while the safety and efficacy of Kazano was demonstrated in four clinical trials involving more than 2,500 patients with type 2 diabetes. Oseni was demonstrated to be safe and effective in four clinical trials involving more than 1,500 patients with type 2 diabetes.

“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. 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.”

Douglas Cole, president, Takeda Pharmaceuticals U.S.A., Inc.

Type 2 diabetes is the most common form of the disease and affects approximately 24 million people and accounts for over 90% of diabetes cases diagnosed in the US.

Takeda is planning to commercially launch Nesina, Oseni and Kazano in the summer of 2013.

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