Sanofi has received a recommendation for European approval of once-daily Lyxumia for the treatment of adults with type 2 diabetes mellitus. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has endorsed the therapy to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin, in cases when these, together with diet and exercise, have proven ineffective on their own. Data from the GetGoal phase III programme has demonstrated the efficacy, safety and tolerability profile of the drug among more than 5,000 test subjects. Sanofi now expects to receive final European approval of lixisenatide within two or three months, while a US regulatory submission is also planned next month.
