Merck and Co's diabetes drug Januvia achieved the main goal of a long-awaited heart safety study.
The Tecos study involved 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.
Significantly, there was no increase in hospitalization for heart failure in the Januvia group versus placebo. That could give Januvia a leg up on rival drugs that have shown a potential heart failure connection.
Full details of the study are expected to be presented at a major diabetes meeting in Boston in June. Sanford Bernstein analyst Tim Anderson said uncertainty over the Tecos study had been an overhang on Merck shares. With the study results, a psychological overhang has been removed and the threat of major downside has been eliminated, Anderson added.
After the preliminary results released on Merck shares rose nearly 4 percent in after-hours trading following the announcement. Januvia had sales of about $4 billion in 2014, plus another $1.8 billion for the related combination product Janumet.
The 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. It was undertaken after heart safety concerns were raised over other diabetes medicines.
Source: Medindia
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