The U.S. FDA rejected Merck & Co. Inc.'s supplemental new drug applications for its diabetes drugs JANUVIA, JANUMET and JANUMET XR.
JANUVIA is known chemically as sitagliptin, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUMET is a combination product with sitagliptin and metformin HCl, with the same indications when treatment with the drug combination is appropriate.
With the applications, the company seeks to include heart safety data from a clinical study in the prescribing information of sitagliptin-containing medicines. It is also reviewing the FDA's complete response letter regarding the applications and will discuss the next steps with the regulator.
The trial achieved its primary composite cardiovascular endpoint of non-inferiority compared to usual care without sitagliptin. There was no increase in hospitalization for heart failure and rates of all-cause mortality were similar in both treatment groups, which were two key secondary endpoints.