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Zealand Pharma A/S' Partner Sanofi Announces Positive Opinion for Lyxumia from CHMP


Friday, 16 Nov 2012 07:50am EST 

Zealand Pharma A/S announced that its partner Sanofi has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency, recommending the approval of once-daily Lyxumia (lixisenatide) for the treatment of adults with Type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. The CHMP positive opinion will be forwarded to the European Commission. A formal decision by the Commission is expected in coming months. Lyxumia (lixisenatide) is a once-daily GLP-1 agonist with a pronounced post-prandial glucose lowering effect. Sanofi has evaluated the efficacy, safety and tolerability profile of lixisenatide in the global Phase III clinical trial program, GetGoal. GetGoal included a number of patients studied to evaluate a GLP-1 receptor agonist in combination with basal insulin. The CHMP opinion is based on results from GetGoal Phase III program, which showed that once-daily lixisenatide significantly reduced HbA1c, glycated haemoglobin, in patients with Type 2 diabetes and showed an associated reduction in post-prandial glucose and a beneficial effect on body weight. The GetGoal program also showed that lixisenatide was well-tolerated overall, with only mild and transient adverse effects (primarily nausea, vomiting, and diarrhea) and a limited risk of hypoglycaemia.