Takeda Pharmaceutical Company Limited (Takeda), the largest pharmaceutical company in Japan and its wholly-owned subsidiary, Takeda Pharmaceuticals USA, Inc. has received the United States Food and Drug Administration (FDA) approval for Nesina (alogliptin) and the fixed-dose combination (FDC) therapies Oseni (alogliptin and pioglitazone) and Kazano (alogliptin and metformin HCl) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.
“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,” said Douglas Cole, president, Takeda Pharmaceuticals USA, Inc. “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.”
Nesina is a dipeptidyl peptidase-4 inhibitor (DPP-4i) that is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). Oseni, which combines alogliptin with pioglitazone, is the first product in the US to include both a DPP-4i and a thiazolidinedione (TZD) in a single tablet. Kazano combines alogliptin with metformin HCl, a widely used anti-diabetes medication, in a single tablet.
The most common adverse events (=4%) reported with Nesina include nasopharyngitis, headache and upper respiratory tract infection. With regard to Oseni, common adverse events (=4%) reported include nasopharyngitis, back pain and upper respiratory tract infection. Common adverse events (=4 %) reported with Kazano include upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain and urinary tract infection.
Takeda is committed to providing type 2 diabetes patients with treatment options that help address their needs, and is planning to commercially launch Nesina, Oseni and Kazano in the summer of 2013.
Takeda’s consolidated financial statements for the 2012 fiscal year will not be impacted by the FDA approvals.
Takeda Global Research & Development Centre, Inc. has conducted worldwide placebo and active-controlled clinical trials of nesina involving more than 13,000 patients. The safety and efficacy of nesina was studied as a once-daily monotherapy and in combination with several other classes of anti-diabetic medications, including biguanides, TZDs, insulin and sulfonylureas. In these studies, Nesina 25 mg, taken once daily, demonstrated clinically meaningful and statistically significant improvements in hemoglobin A1C compared to placebo.
Of the total number of patients included in the Nesina clinical trial program, more than 3,000 were included in the studies used to support the FDA approval of Oseni, and more than 4,000 were included in those to support the FDA approval of Kazano. Study results indicated that alogliptin co-administered with either pioglitazone or metformin HCl produced significant improvements in glycemic control as compared to the respective monotherapies.
Type 2 diabetes is the most common form of diabetes affecting millions of people globally. Type 2 diabetes is a progressive and chronic condition and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take multiple medications in order to help them manage their blood glucose levels. According to the International Diabetes Federation, the global health care expenditures for diabetes (both type 1 and 2) were estimated at $471.6 billion in 2012. By 2030, this number is projected to exceed $595 billion.
Nesina is a DPP-4 is for the treatment of type 2 diabetes as an adjunct to diet and exercise. DPP-4 is slow the inactivation of incretin hormones GLP-1 and GIP. As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels. A New Drug Application (NDA) for Nesina was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is available under the same brand name in Japan.
Oseni is an FDC therapy which combines alogliptin and pioglitazone in a single tablet, for the treatment of type 2 diabetes in adults as an adjunct to diet and exercise. Pioglitazone is a TZD that decreases insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels, and is approved in adults for the treatment of type 2 diabetes as an adjunct to diet and exercise. An NDA for alogliptin and pioglitazone was approved in July 2011 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is currently available under the brand name Liovel in Japan.
Kazano is an FDC therapy for the treatment of type 2 diabetes, which combines alogliptin and metformin HCl in a single tablet. Metformin HCl is a biguanide, a widely used anti-diabetes medication that acts primarily by reducing the amount of glucose produced by the liver.