Merck & Co., has received the US FDA approval for Janumet, the first and only tablet combining a dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin and metformin for the treatment of type 2 diabetes.
Janumet has been approved, as an adjunct to diet and exercise, to improve blood sugar (glucose) control in adult patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone, or in patients already being treated with the combination of sitagliptin and metformin. Janumet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. The price of twice-daily Janumet will be $4.86 per day.
The FDA approved Janumet based upon clinical data including sitagliptin plus metformin as separate tablets. A clinical bioequivalence study has demonstrated the equivalence between Janumet and sitagliptin plus metformin as separate tablets.
"Janumet is the latest advance in Merck's longstanding commitment to developing effective medicines for type 2 diabetes," said Adam Schechter, president, United States Human Health, Merck & Co., Inc. "With Janumet and Januvia, Merck now has a growing family of products that provides physicians with important treatment options for patients with type 2 diabetes."
Janumet combines two agents with proven ability to deliver significant improvements in glycaemia control metformin, a commonly used effective glucose-lowering agent, and sitagliptin, a DPP-4 inhibitor that provides significant A1C lowering as monotherapy and as add-on therapy to metformin or thiazolidinediones (TZDs) based on clinical trials. Janumet, like metformin, is dosed twice daily with meals. Consistent with the labelling for metformin alone, the labelling for Janumet contains a boxed warning for lactic acidosis, a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with Janumet.
"Physicians use several different medications in combination to address the multiple defects associated with type 2 diabetes, however, less than half of patients achieve and maintain their goal A1C levels," said Nir Barzilai, of Medicine and Molecular Genetics, director of the Institute for Aging Research, Albert Einstein College of Medicine. "Janumet is an important new treatment option for many patients who need more than one therapy to control their type 2 diabetes because it addresses all three key defects of type 2 diabetes for improved glycaemia control."
Patients treated with Janumet experienced weight loss comparable to metformin alone, with no increased risk of hypoglycaemia, edema, or GI disturbances beyond metformin alone. As clinicians select agents to add to the treatment regimens of patients with uncontrolled type 2 diabetes, it is important to consider issues such as weight gain, hypoglycaemia, edema, and gastrointestinal disturbances.