Merck receives Complete Response Letter from the U.S. FDA for TECOS study with sitagliptin.

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck’s Supplemental New Drug Applications for Januvia (sitagliptin), Janumet (sitagliptin and metformin HCl) and Janumet XR (sitagliptin and metformin HCl extended-release).

With these applications, Merck is seeking to include data from TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) in the prescribing information of sitagliptin-containing medicines. Merck is reviewing the letter and will discuss next steps with the FDA.

The Januvia (sitagliptin) 25 mg, 50 mg and 100 mg tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. 

Januvia has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking Januvia, according to Merck.

Janumet is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. Janumet XR is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin extended-release is appropriate.

Janumet or Janumet XR should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. They have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking Janumet or Janumet XR.

(Source: Business Wire)