COMMENTARY

Alogliptin's Approval Woes

Matthew L. Mintz, MD

Disclosures

April 27, 2012

In This Article

Better Late Than Never?

Alogliptin was meant to be the first dipeptidyl peptidase-4 (DPP-4) inhibitor on the US market a few years ago, offering a new treatment option for type 2 diabetes. Instead, it became an unintended victim of new safety rules established by the US Food and Drug Administration (FDA) in 2008, prompted partly by concerns over the drug rosiglitazone (Avandia®, GlaxoSmithKline).[1] Those rules now require that all new diabetes medications demonstrate cardiovascular safety, in addition to meeting general safety and efficacy standards.

When the FDA initiated the new requirements, alogliptin (Nesina®,Takeda) was ahead of other DPP-4s in the pipeline. In fact, it was far enough in development that the manufacturer essentially had to start from scratch in designing new clinical trials. Meanwhile, the other competing drug makers were able to adjust their trials to meet the new FDA criteria. As a result, sitagliptin (Januvia®, Merck) was the first DPP-4 to reach the US market, which it continues to dominate.

By now, 2 other DPP-4 inhibitors also have been launched in the United States: saxagliptin (Onglyza®, AstraZeneca and Bristol-Myers Squibb) and linagliptin (Tradjenta®, Boehringer Ingelheim and Lilly).

Takeda expected to finally receive FDA approval for alogliptin in March, but again it was sent away with requests for more data. The company says it is confident that it can provide that information in a timely manner, but what role will alogliptin play if it is approved?

Being fairly late to the party in an already crowded drug class, alogliptin arrival wouldn't have the same impact as if it had been the first DDP-4 inhibitor on the US market as originally planned. It has already been approved for use in Japan, but several factors may determine whether it becomes a useful option in the United States.

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