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FDA Approves Three Alogliptin Drugs for Type 2 Diabetes

Therapies indicated for blood sugar control in conjunction with diet and exercise (Jan. 25)

The FDA has approved three new related drugs 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. All three drugs are distributed by Takeda Pharmaceuticals.

Alogliptin is a new active ingredient, while metformin hydrochloride and pioglitazone are already FDA-approved for the management of type 2 diabetes. As the most common form of the disease, type 2 diabetes affects approximately 24 million people and accounts for more than 90% of diabetes cases diagnosed in the U.S.

Nesina, Kazano, and Oseni were studied as monotherapies and in combination with other type 2 diabetes drugs, including sulfonylureas and insulin. They should not be used to treat patients with type 1 diabetes or those who have increased ketones in their blood or urine (diabetic ketoacidosis).

Nesina (alogliptin) was shown to be safe and effective in 14 clinical trials involving approximately 8,500 patients with type 2 diabetes.

  • Treatment with Nesina resulted in reductions in glycosylated hemoglobin (HbA1c) — a measure of blood sugar control — of 0.4% to 0.6% compared with placebo after 26 weeks of use.
  • 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, including a dose-finding study and two safety and efficacy studies — one with Nesina as monotherapy and one with Nesina and metformin.
  • The most common side effects of Nesina are stuffy or runny nose, headache, and upper respiratory tract infection (URTI).

The safety and efficacy of Kazano (alogliptin and metformin hydrochloride) were demonstrated in four clinical trials involving more than 2,500 patients with type 2 diabetes.

  • Treatment with Kazano resulted in additional reductions in HbA1c of 1.1% over Nesina and 0.5% over metformin after 26 weeks of use.
  • 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.
  • The drug’s labeling carries a boxed warning for lactic acidosis 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 URTI.

Oseni (alogliptin and pioglitazone) was demonstrated to be safe and effective in four clinical trials involving more than 1,500 patients with type 2 diabetes.

  • Treatment with Oseni resulted in additional reductions in HbA1c of 0.4% to 0.6% compared with pioglitazone monotherapy and 0.4% to 0.9% compared with alogliptin monotherapy.
  • The FDA is requiring an enhanced pharmacovigilance program for Oseni to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions.
  • The labeling for Oseni includes 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 URTI.

Source: FDA; January 25, 2013.

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