Merck & Co. has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its supplemental new drug applications (sNDAs) for Januvia (sitagliptin), Janumet (sitagliptin and metformin HCl), and Janumet XR (sitagliptin and metformin HCl extended-release), Merck’s blockbuster anti-diabetes drugs. Januvia, currently indicated as an adjunct to diet and exercise to improve glycemic control in Type 2 diabetes mellitus, and Janumet/Janumet XR, combination sitagliptin and metformin drugs approved for the same indication, are top-selling products in Merck’s diabetes franchise. Januvia had 2016 sales of $3.9 billion and Janumet had 2016 sales of $2.2 billion.

With the sNDAs, Merck was seeking to include data in the drugs’ prescribing information from a clinical trial studying cardiovascular outcomes with sitagliptin, the active ingredient in Januvia and one of the active ingredients in the Janumet and Janument XR combination formulations. Merck is reviewing the letter and said it will discuss next steps with the FDA. 

Source: Merck & Co.