WASHINGTON (AP) -- The Food and Drug Administration on Friday approved three new formulations of a Takeda Pharmaceuticals Co. Ltd. diabetes drug designed to help patients control their blood sugar.
The common ingredient in all three drugs is a new compound called alogliptin, which stimulates the release of insulin, a hormone that controls blood-sugar levels. The FDA approved the drug in stand-alone form under the brand-name Nesina. The drug will also be sold in combination with metformin, under the name Kazano, and with pioglitazone, as Oseni. Metformin is a diabetes drug that has been used for decades. Pioglitazone is a newer diabetes drug sold by Takeda as Actos.
All three new drugs were approved for patients with type 2 diabetes, the most common form of the disease that affects about 24 million Americans. People with the disease have excessive levels of sugar in their blood, which can lead to heart attacks, kidney problems, blindness and other serious complications.
The FDA created tougher cardiovascular-safety standards for diabetes drugs in December 2008 after concerns were raised about certain treatments such Avandia, which was found to increase the risk of heart attacks.
Last year the patent on Takeda's best-selling diabetes drug Actos expired, allowing generic drugmakers to market cheaper versions. Nesina gives the company a new exclusive medicine in the diabetes market.