FDA rejects CV outcomes claim for Merck diabetes drugs

Pharma Times ------ The US Food and Drug Administration has dealt Merck & Co a blow in turning down its request to have cardiovascular outcomes data added to the labels of its diabetes drugs Januvia and Janumet. Merck (which is known as MSD outside of the US and North America) is seeking to include data from TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) in the prescribing information of sitagliptin-containing medicines. In April 2015, Merck reported that Januvia, a DPP-4 inhibitor first approved in the US in 2006, met the main goal of the 14,724-patient TECOS trial of showing non-inferiority for the composite cardiovascular endpoint - the time to the first of any of the following confirmed events: CV-related death, non-fatal myocardial infarction, non-fatal stroke or unstable angina requiring hospitalisation. To learn more click on the picture below to read the article.