Merck's Januvia meets in CV outcomes trial

Merck & Co. Inc. (NYSE:MRK) said the TECOS cardiovascular outcomes trial (CVOT) of Januvia sitagliptin met the primary endpoint of non-inferiority vs. placebo in time to first CV event.

The results add to the evidence base of diabetes drugs that show no major CV risk, reinforcing patient and physician arguments that FDA should reconsider its 2008 guidance requiring diabetes companies to conduct post-market CVOTs. Some panel members at this month's meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) said the agency should either abandon the CVOT requirement or refocus outcomes studies on issues that matter to patients and physicians (see BioCentury, April 27). ...