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IQWiG rebuffs Lyxumia for Type II diabetes

June 18, 2013 12:38 AM UTC

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."

Sanofi did not submit data indirectly comparing Lyxumia in combination with sulfonylurea vs. sulfonylurea plus metformin, another comparator requested by G-BA. Additionally, IQWiG rejected data submitted by Sanofi indirectly comparing Lyxumia plus metformin and sulfonylurea vs. basal insulin plus metformin and sulfonylurea because G-BA had requested Sanofi compare Lyxumia plus metformin and sulfonylurea vs. metformin and human insulin. ...



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