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FDA reviewers question Sanofi's iGlarLixi
May 24, 2016 12:21 AM UTC
In Sanofi (Euronext:SAN; NYSE:SNY), FDA reviewers again raised concerns about a combination therapy whose components include both a fixed-dose stand-alone product and a therapy that is titratable based on a patient's glycemic levels.
On Wednesday, FDA's Endocrinologic and Metabolic Drugs Advisory Committee is to discuss NDAs from Sanofi for glucagon-like peptide-1 receptor ( GLP-1R; GLP1R) agonist lixisenatide ( ZP10) alone, and for a fixed-ratio combination of lixisenatide and the pharma's Lantus insulin glargine. In its own briefing document, Sanofi calls the combination product iGlarLixi. ...