A new injectable drug therapy for people with type 2 diabetes has been approved by the European Commission.
Multinational pharmaceutical company Sanofi has revealed that its latest diabetes product, Lyxumia (lixisenatide), has received Marketing Authorisation in Europen, meaning the firm can now offer the drug for treatment of adults with type 2 diabetes in combination with oral anti-diabetic medicines and/or insulin.
The EC approval of the once-daily GLP-1 agonist is based on results from the GetGoal Phase III clinical programmen, which included 11 clinical trials involving more than 5,000 adult type 2 diabetes patients.
Lyxumia demonstrated significant reductions in blood glucose levels, a pronounced postprandial glucose-lowering effect and a beneficial effect on body weight, and also showed a favourable safety and tolerability profile in most patients.
Pierre Chancel, senior vice-president of global diabetes at Sanofi, said: “With the European approval of Lyxumia, we now have a simple new tool to help patients with type 2 diabetes further reduce HbA1c, with the benefit of weight loss and limited risk of hypoglycaemia.
“This well-tolerated therapy is of specific interest to patients who are on oral treatments and/or basal insulin and do not manage to maintain their HbA1c targets.
“With a single daily injection and only one step to maintenance dose, Lyxumia is a positive addition to the Sanofi portfolio.”
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