Three New Drugs Approved for Type 2 Diabetes
MONDAY Jan. 28, 2013 -- Three new related drugs designed to improve blood sugar control in people with type 2 diabetes have been approved by the U.S. Food and Drug Administration.
All three drugs contain a new active ingredient, alogliptin (brand named Nesina), either by itself or with other previously approved medications. In addition to Nesina, the agency approved Kazano (alogliptin and metformin hydrocholoride) and Oseni (alogliptin and pioglitazone).
Type 2 diabetes leads the body to resist insulin or to produce insufficient amounts of the hormone, causing blood sugar to spike. The disease affects about 24 million people in the United States, accounting for more than 90 percent of diabetes cases, the FDA said in a news release.
Nesina, either by itself or in combination with other medications, was tested in 14 clinical studies involving some 8,500 people with type 2 diabetes. The new drugs should not be used by people with type 1 diabetes, or by people who have high amounts of ketones in the blood or urine, the FDA said.
The most common side effects of alogliptin included runny nose, headache and upper respiratory tract infection. Additional adverse reactions were reported among people who used the combination medications.
Kazano's label will include a "black box" warning of the possibility of lactic acidosis, a buildup of lactic acid in the blood.
All of the new medications are distributed by Takeda Pharmaceuticals America, based in Deerfield, Ill.
The FDA has more about this approval.
Posted: January 2013