Regulatory Affairs

FDA rejects Merck's application to add heart data to labelling for diabetes drugs

PBR Staff Writer Published 10 April 2017

Merck has received a complete response letter from the US Food and Drug Administration (FDA) seeking to add cardiovascular outcomes data from the TECOS study to the labels of J Januvia (sitagliptin), Janumet (sitagliptin and metformin), and Janumet XR (sitagliptin and metformin extended-release).

The company intends to provide data from trial evaluating cardiovascular outcomes with sitagliptin (TECOS), which includes prescribing information of sitagliptin-containing medicines.

The TECOS trial, which involved 4,724 patients with type-2 diabetes, demonstrated that adding sitagliptin will not increase major heart problems compared against placebo, as per the results announced in 2015.

Merck said that it will review the letter and will discuss next steps with the FDA.

Januvia is a once-daily prescription pill, along with diet and exercise, will enable to reduce blood sugar levels in adults with type 2 diabetes.

It is used as an adjunct to diet and exercise to enhance glycemic control in adults with type 2 diabetes mellitus. It cannot be used for patients with type 1 diabetes and to treat diabetic ketoacidosis.

According to the company, Januvia is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.

The incidence of hypoglycemia was increased compared to placebo, when Januvia was used in combination with a sulfonylurea or insulin.

Janumet can be used 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 enhance glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin extended-release is appropriate.


Image: The FDA campus at 10903 New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.