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SGLT2i

Sota/Dapa T1DM EU Regulatory Analysis; Sota Receives Positive CHMP Opinion

Here is a brief preview of this blast: CHMP has adopted a positive opinion for the use of 200 and 400mg Zynquista (sotagliflozin) in T1DM.  Recall, on January 31, CHMP adopted a positive opinion for the use of Forxiga in T1DM (previous FENIX insight). Of note, the proposed limitations for use of both Zynquista and Forxiga are identical. Below, FENIX provides insights from the Zynquista positive CHMP opinion and potential read-through to the upcoming Zynquista FDA action date.

About The Author

Matthew Maryniak

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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.