FDA accepts two more Januvia sNDAs

USA-based drug major Merck & Co says that the Food and Drug Administration has accepted two supplemental New Drug Applications for its diabetes medication Januvia (sitagliptin). One of the filings seeks clearance for use of the product in combination with metformin and diet, as an initial therapy designed to improve glycemic control in diabetic patients.

The second sNDA requests FDA approval for use of the drug as an addition to both sulfonylurea, and diet and exercise, when suitable levels of glycemic control are not achieved using either sulfonylurea alone, or sulfonylurea plus metformin.

Merck also said that it has included data from trials which support both sNDAs as part of its submission to the FDA, adding that some of the findings were presented at the European Association for the Study of Diabetes last year (Marketletter September 25, 2006). The firm said the trial results demonstrated that 66% of those treated with Januvia plus metformin achieved target A1C levels, versus 38% of those who received metformin alone.