Takeda's Nesina doesn't raise the risk of death in diabetic ACS patients, new analysis says


NEW ORLEANS--Takeda already knew from 2013 results of a cardiovascular outcomes trial that its Type 2 diabetes med, Nesina, didn’t increase the risk of CV events for ACS patients when compared with placebo. But now it knows the same is true of the risk of death.

Among Type 2 diabetes patients with ACS, death from any cause occurred in 5.7% of patients in the EXAMINE trial’s Nesina arm, compared with 6.5% of those taking placebo, according to a post hoc analysis presented over the weekend at the annual meeting of the American Diabetes Association. 

It’s good news for the Japanese drugmaker, which needs to hang on to as many patients as possible if it wants to begin to fill the sales hole left by blockbuster Actos. The now-off-patent med raked in more than $16 billion in branded U.S. sales over its lifetime, accounting for half of Takeda’s U.S. revenues and 18% of its worldwide sales.

And Nesina--along with related combo meds Kazano and Oseni, which join active ingredient alogliptin with metformin and Actos API pioglitazone, respectively--was hardly the first to hit the DPP-4 scene, which is dominated by Merck ($MRK) behemoth Januvia.

Meanwhile, though, the entire DPP-4 class is feeling the heat thanks to meds from rival classes that recently demonstrated they could do more in the CV department. Last year, Eli Lilly ($LLY) and Boehringer Ingelheim’s SGLT2 player Jardiance became the first diabetes drug to show it could actually provide a cardiac benefit, cutting down on the combined risk of CV death, heart attack and stroke. And more recently, Novo Nordisk’s ($NVO) GLP-1 Victoza accomplished the same feat, though data on just how well it performed won’t be presented at ADA until Tuesday.

- read Takeda's release

Special Report: The New Drug Approvals of 2013 - Nesina - Takeda

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