Merck Gets Complete Response Letter on TECOS Trial

FDA has issued Merck a complete response letter on supplemental NDAs for Januvia (sitagliptin), Janumet (sitagliptin and metformin HCl) and Janumet XR (sitagliptin and metformin HCl extended-release). In these applications, Merck is seeking to include data from TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) in the prescribing information of sitagliptin-containing medicines. The company says it is reviewing the letter and will discuss its next steps with the agency shortly.

The trial was designed to find out if giving people with Type 2 diabetes sitagliptin alongside their usual diabetes care regime can reduce their risk of heart attacks and strokes. Results published earlier this year showed that among older patients with well-controlled Type 2 diabetes and cardiovascular disease, sitagliptin had neutral effects on cardiovascular risk and raised no significant safety concerns.