According to the FDA, the wellbeing of 24 million Americans is affected by type 2 diabetes, and this accounts for over 90% of all diabetes cases in the country. When you have type 2 diabetes, your blood levels are too high either because you do not produce enough insulin, or you are resistant to it. This not only effects your wellness in the short term, but type 2 diabetes can also lead to other severe complications, such as kidney damage, blindness and heart disease.
The tablets are known as Nesina (alogliptin), Oseni (alogliptin and pioglitazone), and Kazano (alogliptin and metformin hydrochloride), and whilst two of the active ingredients are already approved by the FDA for type 2 diabetes management, Alogliptin is new. ‘Controlling blood sugar levels is very important in the overall treatment and care of diabetes, said Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Centre for Drug Evaluation and Research. ‘Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control’.
Nesina, Oseni and Kazano were studied as a therapy which works in combination with insulin and sulfonylureas, but also as a monotherapy, which is a stand-alone therapy that is not given in combination with another drug. Whilst it was found that they can improve blood sugar control in patients with type 2 diabetes, these therapies should not be prescribed for patients with type 1 diabetes or people with diabetic ketoacidosis, which is a condition where you have high levels of ketones in your urine.
According to Douglas Cole, president of Takeda Pharmaceuticals USA, Inc, ‘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.’