Sota adcom vote split 8-8; on-time approval now in question

Today, the FDA advisory committee panel split the vote (8-8) on whether the sotagliflozin benefit in T1DM outweighs the risks. Of note, the clinicians who treat glycemic control and T1DM tended to vote “yes” while the cardiologists and biostatisticians tended to vote “no.” Below, FENIX provides key highlights of the FDA adcom as well as market implications and read-through to the other SGLT inhibitors being developed for T1DM.

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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