German Regulator Rebuffs Sanofi (France) Diabetes Drug

Published: Jun 19, 2013

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Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said Lyxumia lixisenatide from Sanofi (Euronext:SAN; NYSE:SNY) has "no additional benefit" over comparators requested by Germany's Federal Joint Committee (G-BA). Sanofi did not submit data directly comparing the glucagon-like peptide-1 receptor (GLP-1R) agonist to comparators. The institute said data submitted by the company indirectly comparing Lyxumia with two of the requested comparators -- in combination with metformin vs. sulfonylurea plus metformin, and in combination with basal insulin vs. human insulin -- were not "suitable."

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