* Alogliptin approved alone and in combinations
* Standalone to be sold as Nesina, combos as Kazano, Oseni
* Several postmarketing safety studies required by FDA
Jan 25 (Reuters) - U.S. health regulators approved Takeda Pharmaceutical Co’s alogliptin to treat type 2 diabetes as a standalone drug and in two other formulations in combination pills with older diabetes medicines.
The U.S. Food and Drug Administration announced the three approvals simultaneously on Friday.
Alogliptin by itself will be sold under the brand name Nesina, the agency said. The drug in combination with metformin - one of the most common initial treatments for the disease - will be sold as Kazano, and alogliptin along with pioglitazone - the chemical name for Takeda’s Actos - will be sold as Oseni, the FDA said.
Type 2 diabetes is a growing health crisis that can lead to numerous serious complications, such as heart disease, circulatory problems and amputations, kidney damage, and blindness. It affects about 24 million Americans and accounts for more than 90 percent of diabetes cases diagnosed in the United States, the FDA said.
Alogliptin, which lowers blood sugar levels by stimulating the release of insulin after a meal, was shown to be safe and effective in 14 clinical trials involving about 8,500 patients with type 2 diabetes.
Due to caution about the heart safety of diabetes drugs after GlaxoSmithKline’s Avandia was shown to cause heart problems, the FDA is requiring five postmarketing studies for Nesina, including a cardiovascular outcomes trial to assure that the drug does not increase of the risk of heart attacks or strokes. Another study to be conducted once the drug is being used by the public will monitor for liver abnormalities and serious cases of pancreatitis.
Kazano’s label will include a boxed warning for lactic acidosis, a build-up of lactic acid in the bloodstream associated with metformin use, the agency said.
The Oseni label will have a boxed warning for heart failure associated with pioglitazone use. Pioglitazone belongs to the same class of diabetes drugs as Avandia, known as thiazolidinedione, or TZDs.