AstraZeneca’s Farxiga Fails To Get FDA OK As Insulin Supplement In Type 1 Diabetes
The UK pharma said the FDA had issued a complete response letter, declining its application for using Farxiga in the new T1D indication. Analysts suspect worries over diabetic ketoacidosis risk lie behind the rejection.
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Farxiga, with a new indication to prevent hospitalization for heart failure in type 2 diabetes patients, is the first drug among the SGLT2 class to gain this indication outside of diabetics with renal disease.
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.