February 20, 2007
Merck seeks additional Januvia approvals
Merck has filed applications with the FDA for two additional uses for its diabetes treatment Januvia.
Merck is seeking approval for Januvia for the added indications as an adjunct to diet and exercise, in combination with metformin as initial therapy to improve glycemic control; and as an adjunct to diet and exercise, as add-on therapy to a sulfonylurea plus metformin when dual therapy does not provide adequate glycemic control.
Januvia is currently approved for use as a monotherapy and as add-on therapy to either metformin or thiazolidinediones, to improve blood sugar control in patients with type 2 diabetes when diabetes when diet and exercise are not enough.
Januvia was approved in October 2006. Fourth quarter sales of the drug came in at $42 million.