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FDA Accepts Two Supplemental New Drug Applications for Januvia™

Merck & Co. announced last week that the FDA has accepted for review the use of Januvia as an adjunct to diet and exercise, in combo with metformin as initial therapy and also an add on to sulfonylureas with and without metformin in combination. Merck & Co., Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review two supplemental New Drug Applications (sNDAs) for JANUVIA(TM) (sitagliptin), and the Company expects FDA action on both sNDAs by mid-October.

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 JANUVIA, 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 (TZDs), to improve blood sugar (glucose) control in patients with type 2 diabetes when diet and exercise are not enough. The recommended dose of JANUVIA is 100 mg once daily. In clinical trials, JANUVIA demonstrated an overall incidence of side effects comparable to placebo. The most common side effects reported with JANUVIA (greater than or equal to 5 percent and higher than placebo) were stuffy or runny nose and sore throat, upper respiratory infection, and headache.

"If these sNDAs are approved, the expanded labeling will include indications for use of JANUVIA as initial therapy with metformin and as add-on to any of the three most commonly prescribed classes of oral antihyperglycemic agents," said John Amatruda, M.D., vice president, clinical research, Merck & Co., Inc. "These data further support the broad utility of JANUVIA as an important treatment option for patients with type 2 diabetes."

Phase III data supporting two sNDAs showed a significant mean placebo-subtracted reduction in A1C(1) of 2.1 percent from a mean baseline A1C of 8.7 percent in the patients treated with JANUVIA 50 mg twice daily combined with metformin 1,000 mg twice daily (n=178). In the same study, 66 percent of patients treated with JANUVIA 50 mg twice daily combined with metformin 1,000 mg twice daily achieved goal A1C levels of <7 percent compared to 38 percent of patients treated with metformin 1,000 mg twice daily alone (p <0.01). Even in those patients receiving a lower dose of metformin (JANUVIA 50 mg twice daily and metformin 500 mg twice daily, n=183), significant A1C placebo-subtracted reductions (1.6 percent, p <0.001) and greater goal attainment (43 percent vs. 23 percent with metformin 500 mg twice daily alone, p <0.01) were observed.
The proposed new indications of adding JANUVIA to a sulfonylurea or to a sulfonylurea plus metformin are supported by a 24-week study examining the efficacy and safety of JANUVIA in 441 patients with type 2 diabetes who had inadequate glycemic control on a sulfonylurea alone or a sulfonylurea plus metformin. Results from this Phase III study were submitted to a major medical meeting for presentation later this year.