Three New Drugs for Type 2 Diabetes Approved

By Diane Fennell On January 26, pharmaceutical manufacturer Takeda announced the approval of its Type 2 diabetes drug, Nesina (generic name alogliptin) by the US Food and Drug Administration (FDA). It is the fourth drug in a class of medicines known as DPP-4 inhibitors, joining Januvia (saxagliptin), Onglyza (sitagliptin), and Tradjenta (linagliptin). Approved simultaneously with Nesina were the drugs Kazano (alogliptin and metformin) and Oseni (alogliptin and pioglitazone [brand name Actos]). DPP-4 inhibitors work to lower blood glucose by blocking the action of an enzyme known as dipeptidyl peptidase 4, or DPP-4. DPP-4 breaks down hormones called incretins, which stimulate the release of insulin, slow stomach emptying, inhibit the release of glucagon (a hormone that signals the liver to release glucose), and enhance the survival and growth of the insulin-producing beta cells. With DPP-4 inhibited, the incretins have longer to carry out these actions. Takeda first applied for approval of these medicines in 2007, a year before the FDA tightened its standards for new diabetes drugs; the agency told the manufacturer that it would have to comply with those new standards. Although Takeda resubmitted the application with expanded data, the FDA twice requested more information on the medicines, most recently in April 2012. The safety and effectiveness of Nesina were established through 14 studies that involved a total of 8,500 people with Type 2 diabetes. Those taking Nesina...
Source: Diabetes Self-Management - Category: Diabetes Authors: Source Type: blogs