The European Commission has granted marketing authorisation to Sanofi's Lyxumia (lixisenatide). Lyxumia, the first once-daily prandial GLP-1 receptor agonist, 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 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,” said Pierre Chancel, senior vice president, Global Diabetes at Sanofi. “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.”

The European Commission decision to grant  Marketing Authorisation in Europe for Lyxumia is based on results from the GetGoal clinical programme, which  enabled 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 clinical programme showed that Lyxumia demonstrated significant HbA1c reductions, a pronounced post-prandial glucose lowering effect and a beneficial effect on body weight in adult patients with type 2 diabetes. GetGoal results also showed that Lyxumia had a favourable safety and tolerability profile in most patients, with  mild and transient nausea and vomiting, the most common adverse events observed in the GLP-1 receptor agonist class, and  a limited risk of hypoglycaemia. The international GetGoal programme included 11 clinical trials involving more than 5,000 patients with type 2 diabetes, with a large number of patients studied to evaluate a GLP-1 receptor agonist in combination with basal insulin (706 patients treated with Lyxumia in three trials).

“Lyxumia in combination with oral and / or basal insulin therapies can play a key role in meeting the important need to maintain HbA1c targets for people with type 2 diabetes,” said Dr. Bo Ahrén, MD, PhD, from Lund University in Sweden. “Basal insulin therapies,  while targeting fasting plasma glucose, are able to provide effective control of overall glucose excursion and are able to bring many patients to the target  HbA1c level.  However, as diabetes progresses over time, patients treated with basal insulin may no longer stay at their HbA1c goals, despite good control of fasting plasma glucose. When this happens, adding a medicine such as Lyxumia, which has a pronounced post-prandial glucose lowering effect, may be an effective strategy to further lower blood glucose levels and maintain HbA1c goals.”

Marketing Authorisation in Europe for Lyxumia is applicable to the 27 Member States of the European Union, as well as Iceland, Lichtenstein and Norway, and follows the 15 November 2012 positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency. Applications for regulatory approval  were also submitted  in several other countries around the world and are being reviewed.

Lyxumia (lixisenatide) is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus.  GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells. Lyxumia was in-licensed from Zealand Pharma. Lyxumia is the proprietary name approved by the European Medicines Agency (EMA) for the GLP-1 RA lixisenatide.

Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalised solutions.