FDA Rejects Application to Add Heart Data to Labelling for Merck Diabetes Drugs

TECOS trial indicates no increase in heart problems with sitagliptin

The FDA has issued a complete response letter regarding Merck’s supplemental new drug applications for Januvia (sitagliptin), Janumet (sitagliptin and metformin), and Janumet XR (sitagliptin and metformin extended-release). With these applications, Merck was seeking to include data from the Trial Evaluating Cardiovascular Outcomes With Sitagliptin (TECOS) in the prescribing information of its sitagliptin-containing medications. Merck is reviewing the letter and will discuss the next steps with the FDA.

The company did not disclose the reason for the rejection.

The TECOS trial involved 4,724 patients with type-2 diabetes (T2D) and a history of heart disease. The results, announced in 2015, indicated that adding sitagliptin (Januvia) to usual care did not increase major heart problems compared with placebo. The results also showed no increase in hospitalization rates for heart failure, which had been a particular concern with dipeptidyl peptidase 4 (DPP-4) inhibitors––the drug class to which sitagliptin belongs.

Januvia is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. Janumet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D when treatment with both sitagliptin and metformin is appropriate. And Janumet XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D when treatment with both sitagliptin and metformin extended-release is appropriate.

Sources: Merck; April 7, 2017; and Reuters; April 7, 2017.