Merck & Co., Inc.Merck & Co., Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended two medicines for marketing approval in the European Union (EU).

The CHMP recommended marketing approval for TREDAPTIVE™ (nicotinic acid/ laropiprant, MSD) 1000 mg/20 mg tablets for patients with dyslipidemia or primary hypercholesterolemia. Separately, the U.S. Food and Drug Administration (FDA) is currently reviewing the combination of extended release (ER) niacin and laropiprant under the trademark CORDAPTIVE™ (ER niacin/laropiprant). The CHMP recommendation does not apply to regulatory decisions by the FDA and no inferences should be made about pending FDA regulatory actions based on the recommendation of the CHMP.

In a second opinion, the CHMP recommended marketing approval for JANUMET™ (sitagliptin/metformin HCl) for the treatment of type 2 diabetes. JANUMET was approved by the FDA in March 2007. The U.S. labeling states that JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. JANUMET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUMET has not been studied in combination with insulin. The labeling also includes data supporting use of JANUMET as initial therapy in adults inadequately controlled with diet and exercise alone and for add-on therapy with a sulfonylurea when the combination of a sulfonylurea and metformin does not provide adequate control.

The CHMP issued its positive opinions following a review of comprehensive data supporting the efficacy, safety and tolerability profiles of TREDAPTIVE and JANUMET. EU marketing authorization by the European Commission is expected within 67 days from the date of the CHMP recommendations. If authorized, the decisions will be applicable to the 27 countries that are members of the EU, plus Norway and Iceland.

TREDAPTIVE combines nicotinic acid (niacin) and laropiprant, a novel flushing pathway inhibitor. The proposed indication for TREDAPTIVE is for the treatment of dyslipidemia, in particular in patients with combined mixed dyslipidemia which is characterized by elevated levels of LDL-cholesterol and triglycerides and low levels of HDL-cholesterol, or primary hypercholesterolemia (heterozygous familial and non-familial). TREDAPTIVE should be used in combination with a statin when the cholesterol lowering effect of statins is inadequate, or as monotherapy when statins are considered inappropriate or not tolerated. Diet and other non-pharmacological treatments, such as exercise and weight loss, should continue during therapy with TREDAPTIVE.

JANUMET helps many patients lower blood sugar levels through the powerful efficacy of sitagliptin, a DPP-4 inhibitor, and metformin, a mainstay of diabetes therapy. For patients uncontrolled on metformin alone, JANUMET provides weight loss comparable to metformin alone, with no increased risk of hypoglycemia, edema, or gastrointestinal (GI) disturbances beyond metformin alone.

The CHMP has recommended JANUMET to be indicated to improve glycemic control in patients with type 2 diabetes inadequately controlled on diet and exercise plus their maximally tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. The CHMP also recommended JANUMET to be indicated in combination with a sulfonylurea as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea.

The mechanism of action for JANUMET is distinct in that it targets three core defects – insulin deficiency from beta cells, insulin resistance and overproduction of glucose by the liver. The sitagliptin component in JANUMET targets two of the three key defects. By inhibiting DPP-4, sitagliptin enhances the levels of the body's own active incretins; incretins are natural hormones that increase insulin synthesis and release from pancreatic beta cells and lowers glucagon secretion from pancreatic alpha cells leading to reduced production of glucose by the liver. Metformin targets insulin resistance by increasing the uptake and utilization of glucose. Metformin also decreases production of glucose by the liver in a manner that is complementary to sitagliptin.

In clinical studies, the most common adverse reactions reported, regardless of investigator assessment of causality, in >5 percent of patients and more commonly than in patients treated with placebo were as follows: diarrhea, upper respiratory tract infection and headache (for sitagliptin and metformin combination therapy); nasopharyngitis (for sitagliptin monotherapy); and diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia and headache (due to initiation of metformin therapy).

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