Sanofi and partner Zealand Pharma have been boosted by the news that regulators in Europe have given the green light to their diabetes drug Lyxumia.
The European Commission has granted marketing authorisation in Europe for Lyxumia (lixisenatide), a once-daily prandial GLP-1 receptor agonist. It is indicated for the treatment type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering products and/or basal insulin.
The approval is based on Sanofi's GetGoal Phase III programme, which included 11 clinical trials involving more than 5,000 patients. Pierre Chancel, head of global diabetes at the French drugmaker, said that with the European thumbs-up, "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".
The Lyxumia green light comes just a couple of weeks after the US Food and Drug Administration approved Sanofi and Isis Pharmaceuticals' Kynamro (mipomersen), a 200mg weekly subcutaneous injection for patients with homozygous familial hypercholesterolaemia.