EU approves Lyxumia (Sanofi) to treat adults with Type 2 Diabetes
The EU has granted a marketing authorisation in Europe for Lyxumia (lixisenatide), from Sanofi, for the treatment of Type 2 Diabetes in adults. The decision is based on results from Sanofi�s international GetGoal Phase III program, involving more than 5,000 patients with Type 2 Diabetes in 11 clinical studies.
The results showed that treatment with Lyxumia gave significant HbA1c reductions, a pronounced lowering of post-prandial glucose 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. In the US, a decision on NDA filing acceptance is expected from the FDA in Q1 2013.
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