2/2/2012 4:51 PM ET
(RTTNews) - Merck & Co. Inc. (MRK: News ) said Thursday the US Food and Drug Administration has approved its Janumet XR tablets as a new treatment for type 2 diabetes. The drug will be available in U.S. pharmacies in the next several weeks.
Janumet XR combines sitagliptin, which is the active component of Merck's blockbuster drug Januvia (sitagliptin), with extended-release metformin.
In Merck's fourth quarter 2011, Januvia sales rose 42 percent from last year to $960 million, while Janumet sales improved 34 percent to $386 million.
Janumet XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both sitagliptin and extended-release metformin is appropriate.
The drug is not recommended for use in type 1 diabetes or for the treatment of diabetic ketoacidosis. It has not been studied in patients with a history of pancreatitis.
"Janumet XR is a new treatment that adds once-daily convenience to the powerful efficacy of Janumet for patients with type 2 diabetes," said Barry Goldstein, vice president, Diabetes and Endocrinology, Merck.
"This is important because many patients with type 2 diabetes require treatment with multiple drugs to maintain blood sugar control, and Janumet XR is a new option to help more patients get to their glucose goals."
Janumet XR targets three key defects of diabetes: insulin deficiency from pancreatic beta cells, insulin resistance, and overproduction of glucose by the liver.
The labeling for Janumet XR contains a boxed warning for lactic acidosis, a rare, but serious complication attributed to metformin accumulation.
The drug is also contraindicated in patients with renal impairment; hypersensitivity to metformin HCl; acute metabolic acidosis; history of a serious hypersensitivity reaction to Janumet XR or sitagliptin.
The approval for Janumet XR was based upon a double-blind, placebo-controlled study of 1,091 patients who did not respond adequately to diet and exercise. Results showed that co-administration of metformin immediate-release and sitagliptin twice-daily resulted in a reduction of blood sugar relative to placebo.
The most common adverse reactions reported with sitagliptin and metformin immediate-release as initial therapy compared to metformin immediate-release alone were diarrhea, upper respiratory infection and headache.
Janumet XR is priced comparable to both Januvia and Janumet ((sitagliptin/metformin hydrochloride), on a per-daily-dose basis, Merck said in a statement.
MRK is trading on the NYSE at $38.50, down $0.13 or 0.34%, on a volume of 16.7 million shares.
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by RTT Staff Writer
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