February 6, 2013
After Delays, FDA Approves New Therapies for Lowering Blood Sugar in Type 2 Diabetes
Washington, D.C.—After more than 3 years of delays, the FDA has granted approval for alogliptin, marketed as Nesina, and two related products—Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets—to improve blood sugar control in adults with type 2 diabetes.
Alogliptin, a newly approved active ingredient, 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), according to Takeda Pharmaceuticals, which has sought FDA approval for the compound since 2009.
“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 Center for Drug Evaluation and Research. “Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control.”
The FDA is requiring five postmarketing studies for Nesina, including a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions; and three pediatric studies, including a dose-finding study and two safety and efficacy studies, one with Nesina as a monotherapy and one with Nesina and metformin.
Nesina, demonstrated to be safe and effective in 14 clinical trials involving about 8,500 patients with type 2 diabetes, resulted in glycosylated hemoglobin (HbA1c) reductions of 0.4% to 0.6% compared with placebo after 26 weeks of use. The most common side effects were found to be stuffy or runny nose, headache, and upper respiratory tract infection. None of the alogliptin therapies should be used to treat people with type 1 diabetes or those who have diabetic ketoacidosis, the FDA cautioned.
In clinical trials, the use of Kazano led to additional reductions in HbA1c of 1.1% over Nesina and 0.5% over metformin alone after 26 weeks of use. Two postmarketing studies are being required for Kazano: an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions; and a pediatric safety and efficacy study under PREA. Kazano also carries a boxed warning for lactic acidosis, typical of metformin products.
Oseni, meanwhile, resulted in additional reductions in HbA1c of 0.4% to 0.6% over pioglitazone monotherapy and 0.4% to 0.9 % over alogliptin monotherapy. An enhanced pharmacovigilance program was mandated for Oseni to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions. Oseni also carries a boxed warning for heart failure associated with pioglitazone use.
“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 20 years of clinical and patient experience,” said Douglas Cole, president of Takeda Pharmaceuticals U.S.A., 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.”
The approvals come at an opportune time for Takeda, whose blockbuster diabetes drug, Actos, went off patent last year.
|U.S. Pharmacist Social Connect