FDA approves 3 new diabetes treatments
FDA approves 3 new diabetes treatments
The FDA has approved three drugs with the new active ingredient alogliptin -- Nesina (alogliptin), Oseni (alogliptin and pioglitazone) and Kazano (alogliptin and metformin HCl) -- as adjunct treatments to diet and exercise for adults with type 2 diabetes.
"Controlling blood sugar levels is very important in the overall treatment and care of diabetes," Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research said in a press release. “Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control.”Pioglitazone and metformin hydrochloride were already FDA-approved for the management of type 2 diabetes.
Nesina, Kazano, and Oseni were studied as stand-alone therapies (monotherapies) and in combination with other type 2 diabetes therapies, including sulfonylureas and insulin. They should not be used to treat people with type 1 diabetes or those who have increased ketones in their blood or urine (diabetic ketoacidosis), the FDA warns.
Nesina is a dipeptidyl peptidase-4 inhibitor (DPP-4i) that slows the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). It's approval was based on 14 clinical trials involving about 8,500 patients with type 2 diabetes.
Patients assigned to Nesina experienced 0.4% to 0.6% reductions in HbA1c after 26 weeks compared with those assigned to placebo. Common side effects include stuffy or runny nose, headache and upper respiratory tract infection.
As part of the approval, the FDA is requiring Takeda to conduct five post-marketing clinical trials to assess cardiovascular outcomes, the potential for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions; and a dose finding study and two safety and efficacy studies in pediatric patients, one with Nesina as a monotherapy and one with Nesina and metformin.
Oseni, which combines alogliptin and pioglitazone, is the first drug to include both a DPP-4i and a thiazolidinedione (TZD) in a single tablet. It's safety and efficacy was assessed in four clinical trials involving more than 1,500 patients with type 2 diabetes.
Oseni reduced HbA1c levels 0.4% to 0.6% more than pioglitazone monotherapy and 0.4% to 0.9% more than alogliptin monotherapy, study results indicate. The most common side effects of Oseni are stuffy or runny nose and sore throat, back pain and upper respiratory infection.
The medication will carry a boxed warning for heart failure associated with pioglitazone use, and the FDA is requiring an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis and severe hypersensitivity reactions.
Kazano combines alogliptin with metformin HCl, a biguanide also indicated for the treatment of diabetes. It's approval was based on four clinical trials involving more than 2,500 patients with type 2 diabetes that showed Kazano reduced HbA1c 1.1% over Nesina and 0.5% over metformin after 26 weeks of use.
The most common side effects with Kazano are upper respiratory tract infection, stuffy or runny nose and sore throat, diarrhea, headache, hypertension, back pain and UTI. Kazano will carry a boxed warning for lactic acidosis associated with metformin use.
The FDA is requiring Takeda conduct two postmarketing studies -- one to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions, and a second pediatric safety and efficacy study.
Takeda plans to launch Nesina (6.25mg, 12.5mg, 25mg tablets), Oseni (25mg/15mg, 25mg/30mg, 25mg/45mg, 12.5mg/15mg, 12.5mg/30mg, and 12.5mg/45mg tablets), and Kazano (12.5mg/500mg and 12.5mg/1000mg tablets) in the summer of 2013.