Newly approved type 2 diabetes drugs come with warnings, requirements

diabetes illus250x03 Newly approved type 2 diabetes drugs come with warnings, requirementsAfter more than five years of reviews and rejections, the dipeptidyl peptidase IV (DDP-4) inhibitor alogliptin has finally been approved by the Food and Drug Administration (FDA). The new drug was approved in three versions to improve blood sugar control in adults with type 2 diabetes.

Nesina contains alogliptin as a single-agent drug; Kazano contains alogliptin with metformin; and Oseni contains alogliptin with pioglitazone. The drugs are to be prescribed in combination with diet and exercise.

Alogliptin is the fourth DDP-4 inhibitor to gain FDA clearance. Others include sitagliptin, sold under the brand name Januvia; saxagliptin, sold as Onglyza; and linagliptin, sold as Tradjenta. The new drug is manufactured by Takeda Pharmaceutical Company.

Alogliptin hit several snags on the road to FDA approval. Takeda first submitted an application for drug approval in 2008, not long after concerns were being raised about the fatal heart attacks in patients who used type 2 diabetes drug Avandia (rosiglitazone).

The FDA began requiring all diabetes therapies to demonstrate cardiovascular safety. Thus, Takeda had to restart its clinical trials to identify cardiovascular risks. During that time, Takeda also was asked to provide more information on alogliptin, both as a single agent and combined with pioglitazone, because of safety concerns.

Then, in 2011, the FDA issued a bladder cancer warning for Takeda’s Actos, the brand-name version of pioglitazone.

Takeda has been tireless in its effort to gain FDA approval for all three versions of alogliptin. The FDA ultimately granted the approvals but with various warnings and requirements. Post-marketing studies must be done on all drugs to monitor liver abnormalities, serious cases of pancreatitis, and severe hypersensitivity reactions.

Kazano, the metformin combination drug, will also carry a black box warning for lactic acidosis. Oseni, the pioglitazone combination drug, will have a boxed warning for heart failure.

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