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news.The FDA has accepted for review two supplemental new drug applications from Merck & Co. requesting new uses for the diabetes drug Januvia.
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One application 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 application 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.
The proposed new indication of Januvia in combination with metformin as initial therapy is supported by a 24-week study in type 2 diabetes. The company expects FDA action on both applications by mid-October.
“These data further support the broad utility of Januvia as an important treatment option for patients with type 2 diabetes,” said John Amatruda, vice president of clinical research at Merck & Co.