Merck's diabetes drug Januvia succeeds in heart safety trial

[April 28, 2015]  By Bill Berkrot

(Reuters) - Merck and Co's diabetes drug Januvia achieved the main goal of a long-awaited heart safety study, according to preliminary results released by the drugmaker on Monday, likely removing a cloud of uncertainty from its biggest product.

Merck shares rose nearly 4 percent in after-hours trading following the announcement on Januvia, which had sales of about $4 billion in 2014, plus another $1.8 billion for the related combination product Janumet.

In the Tecos study of 14,724 patients with type 2 diabetes and a history of heart disease, Januvia plus regular care led to no significant difference in a composite of time to the first cardiovascular-related death, non-fatal heart attack, non-fatal stroke, or unstable angina requiring hospitalization compared with usual care alone, Merck said.

Among secondary goals of the study, there was no increase in hospitalization for heart failure in the Januvia group versus placebo, Merck said.

Full details of the study are expected to be presented at a major diabetes meeting in Boston in June, the company said.

The Tecos heart safety study was conducted by an independent academic research collaboration between the University of Oxford Diabetes Trials Unit and the Duke University Clinical Research Institute, and was undertaken after heart safety concerns were raised over other diabetes medicines.

Earlier this month, a panel of expert advisers to the U.S. Food and Drug Administration voted that two similar diabetes drugs, AstraZeneca Plc's Onglyza and Nesina from Takeda Pharmaceutical Co, had acceptable cardiovascular risk profiles, although they recommended that their product information labels warn about the risk of heart failure.

The two rival medicines and Januvia belong to a class of diabetes treatments known as DPP-4 inhibitors.

Merck shares rose 3.8 percent to $59.25 in extended trading from their New York Stock Exchange close at $57.10.

(This version of the story adds study details and background)

(Reporting by Bill Berkrot, additional reporting by Ransdell Pierson; Editing by G Crosse and Alan Crosby)

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