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Next Once-Daily GLP-1 Agonist, Lixisenatide, Approved in EU

Feb 8, 2013

One more GLP-1 agonist gets approved in Europe….

The European Commission has granted approval of lixisenatide (Lyxumia, Sanofi) for the treatment of adults with type 2 diabetes.

The drug, a once-daily glucagon-like peptide 1 (GLP-1) agonist, is indicated to achieve glycemic control in combination with oral glucose-lowering products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.

The approval covers the 27 member states of the European Union, as well as Iceland, Lichtenstein, and Norway, and follows a positive opinion issued by the European Medicines Agency in November.

Lixisenatide was approved in its first market, Mexico, last month, and Sanofi expects to file for US approval of lixisenatide in the first quarter of this year. Sanofi licensed rights to the product from Denmark’s Zealand Pharma.

Lixisenatide will compete with other GLP-1 agonists, including once-daily liraglutide (Victoza, Novo Nordisk) — considered the “gold standard” — and exenatide (Bydureon, Lilly/Amylin Pharmaceuticals), which is now available as a once-weekly injection. Others are in development, including albiglutide, another once-weekly product from GlaxoSmithKline, which was filed for approval in the US last month.

Sanofi News Release 2-4-2013

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