Sanofi’s diabetes drug Lyxumia is approved in EU

Hannah Blake

pharmaphorum

Sanofi’s Lyxumia for type 2 diabetes has been granted marketing authorization in Europe from the European Commission. Lyxumia (lixisenatide) is the first once-daily prandial GLP-1 receptor agonist and is indicated for the treatment of adults with type 2 diabetes mellitus 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.

“With a single daily injection and only one step to maintenance dose, Lyxumia is a positive addition to the Sanofi portfolio, and represents another step forward in our efforts to advance scientific excellence and develop new therapeutic solutions that improve outcomes for people with diabetes, an area of significant unmet medical need.”

Pierre Chancel, Senior VicePresident, Global Diabetes at Sanofi.

The European Commission’s decision to approval in Europe for Lyxumia is based on clinical trial results involving more than 5000 type 2 diabetes patients. The programme, called GetGoal, found Lyxumia to be the first once-daily GLP-1 receptor agonist with a predominantly prandial glucose lowering effect to be indicated for use on top of basal insulin and in combination with oral anti-diabetic medications.

The European approval of lyxumia is applicable to the 27 member states of the European Union, as well as Iceland, Lichtenstein and Norway. Sanofi has also submitted applications for regulatory approval in several other countries around the world and are currently being reviewed.