The Food and Drug Administration has approved three related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets and Oseni (alogliptin and pioglitazone) tablets.
Alogliptin is a new active ingredient, while metformin hydrochloride and pioglitazone already are FDA-approved for the management of type 2 diabetes. As the most common form of the disease, type 2 diabetes affects about 24 million people and accounts for more than 90% of diabetes cases diagnosed in the United States.
"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 news release. "Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control."
Nesina, Kazano and Oseni were studied as 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 diabetic ketoacidosis.
Nesina was demonstrated to be safe and effective in 14 clinical trials involving about 8,500 patients with type 2 diabetes. Nesina resulted in reductions in glycosylated hemoglobin of 0.4% to 0.6% compared with placebo after 26 weeks of use. The most common side effects were stuffy or runny nose, headache and upper repiratory tract infection.
The FDA is requiring five postmarketing studies for Nesina: 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 under the Pediatric Research Equity Act, including a dose-finding study and two safety and efficacy studies, one with Nesina as a monotherapy and one with Nesina and metformin.
The safety and efficacy of Kazano were demonstrated in four clinical trials involving more than 2,500 patients with type 2 diabetes. Kazano resulted in additional reductions in HbA1c of 1.1% over Nesina and 0.5% over metformin after 26 weeks of use.
Kazano carries a boxed warning for lactic acidosis, which has been associated with metformin use. The most common side effects of Kazano are upper respiratory tract infection, stuffy or runny nose and sore throat, diarrhea, headache, hypertension, back pain and urinary tract infection.
The FDA is requiring two postmarketing studies 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.
Oseni was demonstrated to be safe and effective in four clinical trials involving more than 1,500 patients with type 2 diabetes. Oseni resulted in additional reductions in HbA1c of 0.4% to 0.6% over pioglitazone monotherapy and 0.4% to 0.9% over alogliptin monotherapy.
Oseni carries a boxed warning for heart failure associated with pioglitazone use. The most common side effects of Oseni are stuffy or runny nose and sore throat, back pain and upper respiratory infection.
The FDA is requiring an enhanced pharmacovigilance program for Oseni to monitor for liver abnormalities, serious cases of pancreatitis and severe hypersensitivity reactions
Nesina, Kazano and Oseni are distributed by Takeda Pharmaceuticals America Inc., Deerfield, Ill.
Alogliptin is a new active ingredient, while metformin hydrochloride and pioglitazone already are FDA-approved for the management of type 2 diabetes. As the most common form of the disease, type 2 diabetes affects about 24 million people and accounts for more than 90% of diabetes cases diagnosed in the United States.
"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 news release. "Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control."
Nesina, Kazano and Oseni were studied as 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 diabetic ketoacidosis.
Nesina was demonstrated to be safe and effective in 14 clinical trials involving about 8,500 patients with type 2 diabetes. Nesina resulted in reductions in glycosylated hemoglobin of 0.4% to 0.6% compared with placebo after 26 weeks of use. The most common side effects were stuffy or runny nose, headache and upper repiratory tract infection.
The FDA is requiring five postmarketing studies for Nesina: 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 under the Pediatric Research Equity Act, including a dose-finding study and two safety and efficacy studies, one with Nesina as a monotherapy and one with Nesina and metformin.
The safety and efficacy of Kazano were demonstrated in four clinical trials involving more than 2,500 patients with type 2 diabetes. Kazano resulted in additional reductions in HbA1c of 1.1% over Nesina and 0.5% over metformin after 26 weeks of use.
Kazano carries a boxed warning for lactic acidosis, which has been associated with metformin use. The most common side effects of Kazano are upper respiratory tract infection, stuffy or runny nose and sore throat, diarrhea, headache, hypertension, back pain and urinary tract infection.
The FDA is requiring two postmarketing studies 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.
Oseni was demonstrated to be safe and effective in four clinical trials involving more than 1,500 patients with type 2 diabetes. Oseni resulted in additional reductions in HbA1c of 0.4% to 0.6% over pioglitazone monotherapy and 0.4% to 0.9% over alogliptin monotherapy.
Oseni carries a boxed warning for heart failure associated with pioglitazone use. The most common side effects of Oseni are stuffy or runny nose and sore throat, back pain and upper respiratory infection.
The FDA is requiring an enhanced pharmacovigilance program for Oseni to monitor for liver abnormalities, serious cases of pancreatitis and severe hypersensitivity reactions
Nesina, Kazano and Oseni are distributed by Takeda Pharmaceuticals America Inc., Deerfield, Ill.
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