No increased heart risk with Merck & Co diabetes drug Januvia

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Merck and Co has been boosted by the news that a heart safety trial of its diabetes therapy Januvia achieved its primary endpoint, which should provide a further fillip to its biggest-selling product.

Merck shares were up nearly 4% in after-hours trading following the release of data from the Tecos study, which involved 14,724 patients with type 2 diabetes and a history of heart disease. They showed that Januvia (sitagliptin), a DPP_4 inhibitor, achieved its main goal of non-inferiority for the composite cardiovascular endpoint.

Among secondary endpoints, there was no increase in hospitalisation for heart failure in the Januvia group versus placebo. The Tecos trial was led by an independent academic research collaboration between the University of Oxford and Duke University; full details will be presented at the American Diabetes Association in Boston in June.

Earlier this month, advisers to the US Food and Drug Administration voted that two other DPP-4 inhibitors – AstraZeneca’s Onglyza (saxagliptin) and Takeda’s Nesina (alogliptin) had acceptable CV risk profiles but recommended label updates warning about the increased risk of heart failure hospitalisation.

Januvia had sales of about $4 billion in 2014, plus another $1.8 billion for Janumet (sitagliptin plus metformin).