The FDA has issued a complete response letter denying Merck’s application to include cardiovascular information on its drug labels for its diabetes drugs, Januvia and Janumet.
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Within the supplemental new drug application, Merck had requested that information from its Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) be included in the prescribing information of its diabetes drugs. The company is reviewing the letter from the FDA and will be discussing next steps with the organisation shortly.
Januvia is indicated for use in patients with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control. Janumet is also indicated for use in patients with type 2 diabetes, as an adjunct to diet and exercise for glycemic control, when treatment with both sitagliptin and metforming is appropriate.
Primary endpoint results from the TECOS trial, which was a large-scale cardiovascular outcomes study of 14,671 patients with type 2 diabetes, demonstrated that there was no significant difference among sitagliptin treated patients or placebo treated patients regarding cardiovascular risk.