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

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.

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