Sanofi's Sotagliflozin: Risk Of Ketoacidosis Divides US FDA Advisory Committee
Some Endocrinologic and Metabolic Drugs Advisory Committee members said a REMS is sufficient, but others worried that proposed risk management plans were not proven effective.
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Sanofi terminated its alliance for the SGLT1/2 inhibitor Zynquista, giving Lexicon full control of development in type 1 and type 2 diabetes, but it is seeking a new partner ideally with a European footprint.
Lexicon labelled Sanofi’s unilateral decision to exit their alliance ‘invalid’ and said the French drugmaker was thus ‘in breach of contract’. Sanofi said its move was triggered by Phase III trial data studying the dual SGLT1 and SGLT2 inhibitor in type-2 diabetes.
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