FDA Approves Three New Diabetes Medications
The US Food and Drug Administration (FDA) has approved three new types of medications made and distributed by Takeda Pharmaceuticals America Inc, based in Deerfield, Illinois. Nesina (alogliptin) tablets, Oseni (alogliptin and pioglitazone) tablets, and Kazano (alogliptin and metformin hydrochloride) tablets have been approved for the treatment of type 2 diabetes, for use along with diet and exercise.
The drugs are designed to improve blood sugar control.
The International Diabetes Federation (IDF) notes that globally the rate of diabetes is soaring out of control. Over 370 million people worldwide have the disease with another 187 million still yet to be diagnosed. While we work to prevent new cases from occurring with encouraging healthful lifestyle choices, pharmaceutical companies are creating new medications to help control diabetes in those who already have the disease.
Patients with type 2 diabetes either do not produce enough insulin or are resistant to it, causing blood sugar to rise. High blood sugar levels can ultimately lead to serious and life-threatening complications such as heart disease, blindness and kidney disease.
Alogliptin is a new medication which helps stimulate the release of insulin after a meal. It is a DPP-4i – dipeptidyl peptidase-4 inhibitor – which inhibits glucagon release (glucagon increases blood glucose levels) which in turn increases insulin secretion and lowers blood glucose levels. Another medication within this class is sitagliptin (Januvia), approved by the FDA in 2006.
Nesina was shown to be both effective and safe in 14 human studies including over 8500 participants. Patients on the medication had reductions in HBA1c (a long-term measure of glucose control) of 0.4% to 0.6% compared to those on placebo after 26 weeks.
Though the most commonly reported side effects were fairly minor (upper respiratory tract infection, headache and runny nose), the FDA will require Takeda to perform five post-marketing studies to evaluate cardiovascular outcomes, monitor for liver abnormalities and hypersensitivity reactions and three pediatric studies under the Pediatric Research Equity Act (PREA).
Oseni combines alogliptin with pioglitazone, the active ingredient in the diabetes medication Actos. Pioglitazone reduces insulin resistance in the liver and peripheral tissues, increases the expense of insulin-dependent glucose, decreases the withdrawal of glucose from the liver, and reduces the quantity of glucose, insulin and glycated hemoglobin in the bloodstream.
In four clinical trials including over 1500 participants, Oseni was shown to reduce HbA1C 0.41% to 0.9% over alogliptin alone and 0.4% to 0.6% over pioglitazone alone.
Oseni will require a boxed warning on the packaging to alert consumers about heart failure linked to pioglitazone use. The FDA will also require Takeda to include an enhanced pharmacovigilance program to check for abnormalities of the liver and pancreas.
Kazano combines alogliptin with metformin HCl (Glucophage), the first-line drug of choice for type 2 diabetes. In four clinical trials (2500 participants), those on Kazano had additional reductions in HbA1c of 1.1% over Nesina, and 0.5% over metformin after being on therapy for 26 weeks.
Kazano will also require two post-marketing studies to evaluate pediatric efficacy and to check for liver and pancreas abnormalities. Kazano will include a boxed warning regarding lactic acidosis (accumulation of lactic acid in the bloodstream), which is linked to metformin use.
None of the newly approved therapies should be prescribed for patients with type 1 diabetes or people with diabetic ketoacidosis (high ketone urine levels).
Douglas Cole, president of Takeda Pharmaceuticals USA 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."
"FDA approves three new drug treatments for type 2 diabetes" - Food and Drug Administration
"Takeda Receives FDA Approval for Three New Type 2 Diabetes Therapies, NESINA (alogliptin) and Fixed-Dose Combinations OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl)" - Takeda Pharmaceuticals U.S.A., Inc.