Three Type 2 Diabetes Pills From Takeda Approved By FDAMain Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 27 Jan 2013
Nesina (alogliptin) tablets, Oseni (alogliptin and pioglitazone) tablets, and Kazano (alogliptin and metformin hydrochloride) tablets, for the treatment of type 2 diabetes, for use along with diet and exercise, have been approved by the Food and Drug Administration. They are designed to improve blood sugar control.
The active ingredients pioglitazone and metformin hydrochloride are already approved by the FDA for type 2 diabetes management - Alogliptin is new.
According to the FDA in a communiqué issued on January 25th, 2013, 24 million Americans live with type 2 diabetes, which accounts for over 90% of all diabetes cases in the country.
Patients with type 2 diabetes either do not produce enough insulin, or are resistant to it - in both cases their blood sugar levels are too elevated. Eventually, high blood sugar levels can lead to serious and life-threatening complications, such as kidney damage, blindness and heart disease.
Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said:
"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."
Nesina, Oseni and Kazano were studied as monotherapies and also in combination with insulin and sulfonylureas. A monotherapy is a stand-alone therapy, one that is not given in combination with another drug.
These therapies should not be prescribed for patients with type 1 diabetes or people with diabetic ketoacidosis (high ketone urine levels).
Nesina (alogliptin) tabletsNesina is a DPP-4i (dipeptidyl peptidase-4 inhibitor). It is designed to slow down the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide).
Nesina (alogliptin) was shown to be both effective and safe in 14 human studies, which included 8,500 participants; all of them with type 2 diabetes:
Kazano (alogliptin and metformin hydrochloride) tabletsKazano is a combination of alogliptin and metformin HCl, a extensively used anti-diabetes medication, in a single tablet.
Kazano was shown to be both safe and effective in four clinical trials, which included over 2,500 participants, all of them with type 2 diabetes:
Oseni (alogliptin and pioglitazone) tabletsOseni, a combination of alogliptin and pioglitazone, is the first medication in the USA to include both a DPP-4i and a TZD (thiazolidinedione) in a single tablet.
Oseni was shown to be both safe and effective in four clinical trials which included over 1,500 participants, all of them with type 2 diabetes:
Douglas Cole, president, Takeda Pharmaceuticals U.S.A., Inc., said:
"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."
According to Takeda, type 2 diabetes is a "progressive and chronic (long-term) condition." Patients should work with a doctor to manage and monitor their disease. As well as adhering to a diet and exercise program, patients need to take several drugs in order to help them manage their blood glucose levels.
Currently, approximately $471.6 billion are spent annually worldwide on diabetes (both types 1 and 2). The International Diabetes Federation estimates that this yearly expenditure will rise to over $595 billion within the next 17 years.
Written by Joseph Nordqvist
Copyright: MediLexicon International Ltd
Original article posted on Medical News Today.
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