Nesina, Kazano, and Oseni, all based on alogliptin, approved for use with diet and exercise
MONDAY, Jan. 28 (HealthDay News) -- Three new products have been approved by the U.S. Food and Drug Administration to improve blood sugar control in adults with type 2 diabetes, for use as monotherapy or in combination with other therapies and together with diet and exercise.
The three drugs, distributed by Takeda Pharmaceuticals American Inc. in Deerfield, Ill., are based on a new active ingredient, alogliptin. Nesina (alogliptin), Kazano (alogliptin and metformin hydrochloride), and Oseni (alogliptin and pioglitazone) were assessed as both monotherapies and together with insulin and sulfonylureas.
The safety and effectiveness of Nesina was demonstrated in 14 clinical trials involving about 8,500 patients with type 2 diabetes, where Nesina treatment resulted in a 0.4 to 0.6 percent reduction in hemoglobin A1c versus placebo after 26 weeks. In four clinical trials involving more than 2,500 patients, Kazano resulted in a 1.1 percent additional decrease in hemoglobin A1c versus Nesina and a 0.5 percent greater decrease versus metformin over 26 weeks. The safety and efficacy of Oseni was demonstrated in four clinical trials involving more than 1,500 patients, with a reduction of 0.4 to 0.6 percent in hemoglobin A1c versus pioglitazone monotherapy and a 0.4 to 0.9 percent reduction versus alogliptin monotherapy. Kazano and Oseni carry boxed warnings for lactic acidosis and heart failure associated with pioglitazone use, respectively.
"Controlling blood sugar levels is very important in the overall treatment and care of diabetes," Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control."
More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336942.htm )