The European Commission decision to grant Marketing Authorisation in Europe for Lyxumia is based on results from the GetGoal clinical program, 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 program 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 favorable 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 hypoglycemia. The international GetGoal program 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 was in-licensed from Zealand Pharma A/S.
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.