FENIX Analysis: Sotagliflozin FDA Adcom Briefing Documents

Briefing documents for the Sanofi/Lexicon sotagliflozin in T1DM FDA adcom were posted today in advance of the January 17, 2019 meeting. As anticipated, FDA’s primary concern appears to be the increased risk of DKA with sotagliflozin; however, Sanofi/Lexicon’s mitigation strategy is projected to quell the concerns of the FDA adcom voting panel. Below, FENIX provides further analysis of the briefing documents, and in light of this evidence, FENIX predicts the results of the adcom will be positive for Sanofi/Lexicon. Executive Summary The 16-member panel will be asked to respond to 4 discussion questions (sota benefits for T1DM, concern for risk of DKA, differences between……

About The Author

Matthew Maryniak

President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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