The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended Merck’s Tredaptive and Janumet 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, according to the Whitehouse, N.J.-based Merck.
Separately, the FDA is currently reviewing the combination of extended release (ER) niacin and laropiprant under the trademark Cordaptive (ER niacin/laropiprant). The pharmaceutical company said 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, which was approved by the FDA in March 2007, Merck said.
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.
Merck said 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, according to the company. If authorized, the decisions will be applicable to the 27 countries that are members of the EU, plus Norway and Iceland.