Latest DPP-4 Inhibitor, Alogliptin, Reaches US Market

June 18, 2013

The latest dipeptidyl peptidase-4 (DPP-4) inhibitor to be licensed in the United States for the treatment of type 2 diabetes, alogliptin (Nesina, Takeda Pharmaceuticals), has been launched.

Three formulations of alogliptin were approved in January; as well as Nesina, the fixed-dose combination of alogliptin and metformin hydrochloride (Kazano) and alogliptin and pioglitazone( Oseni) are also now available in for use with diet and exercise to improve blood glucose control in adults with type 2 diabetes

Alogliptin is the fourth DPP-4 inhibitor to be licensed in the United States, although it was supposed to be the first. It was already far along in development in 2008 when the Food and Drug Administration (FDA) issued new cardiovascular safety requirements for all new diabetes medications. This meant that Takeda had to start fresh with new trials, while 3 competitors whose drugs were further back in development — sitagliptin (Januvia, Merck), saxagliptin (Onglyza, AstraZeneca/Bristol-Myers Squibb), and linagliptin (Tradjenta, Boehringer Ingelheim/Lilly) — were able to beat alogliptin to market.

Alogliptin was approved in April 2010 in Japan for the treatment of type 2 diabetes, and the therapy is available there, under the same brand name.

The FDA is requiring 5 postmarketing studies for alogliptin, including 3 pediatric studies, a cardiovascular-outcomes trial, and an enhanced pharmacovigilance program to monitor for liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions.

Selective DPP-4 inhibitors work by slowing the inactivation of incretin hormones, such as glucagonlike peptide-1 (GLP-1), involved in regulating blood glucose levels. Along with a related class of diabetes drugs, GLP-1 agonists, DPP-4 inhibitors have recently been linked to a scare about a potential association with pancreatic cancer. The latest data, however, suggest there is no confirmed link as yet but that only time will tell whether this continues to be the case.

The alogliptin/metformin combination will carry a boxed warning about the risk for lactic acidosis. Two postmarketing studies will be required for this formulation.

For alogliptin/pioglitazone, the FDA is requiring enhanced pharmacovigilance for severe adverse events. And, as with pioglitazone, it will carry a boxed warning for heart failure.

Nesina will be available as 6.25 mg, 12.5 mg, and 25 mg tablets; Kazano as 12.5 mg/500 mg and 12.5 mg/1000 mg tablets; and Oseni as 25 mg/15 mg, 25 mg/30 mg, 25 mg/45 mg, 12.5 mg/15 mg, 12.5 mg/30 mg, and 12.5 mg/45 mg tablets.

With regard to the cost of the new medications, Takeda says it aims "to set prices that are both competitive and flexible. Takeda understands the daily challenges patients face in affording their medications and strives to offer our products in the most cost-effective manner possible."

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