US indication for Januvia to be extended
The US Food and Drug Administration (FDA) has accepted for standard review two supplemental New Drug Applications (sNDAs) for Januvia (sitagliptin), from Merck & Co.
The US Food and Drug Administration (FDA) has accepted for standard review two supplemental New Drug Applications (sNDAs) for Januvia (sitagliptin), from Merck & Co.
One sNDA is filed in support of a proposed new indication for the use of Januvia as an adjunct to diet and exercise, in combination with metformin as initial therapy to improve glycemic control.
The other sNDA is filed in support of two proposed new indications for use of the drug, as an adjunct to diet and exercise, as add-on therapy to a sulfonylurea when the single agent alone does not provide adequate glycemic control and as add-on therapy to the combination of a sulfonylurea plus metformin when dual therapy does not provide adequate glycemic control.
Januvia is currently indicated for use as monotherapy and as add-on therapy to either of two other types of oral diabetes medications, metformin or thiazolidinediones , to improve blood sugar (glucose) control in patients with type 2 diabetes when diet and exercise are not enough.