Lyxumia, Sanofi’s Type 2 Diabetes Treatment, Approved in EU

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The European Commission has granted  Marketing Authorisation in Europe for Sanofi’s new type 2 diabetes treatment, Lyxumia (lixisenatide).
Lyxumia 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.

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.

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