AZ's Forxiga Gets Type 1 Diabetes EU Okay As Sanofi Suffers US Setback
Forxiga is the first oral medicine approved in the EU as an adjunct to insulin for type 1 diabetes and the regulatory boost for AstraZeneca comes as Sanofi gets a CRL from the FDA for Zynquista.
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Lexicon’s announcement of two positive cardiovascular outcome studies was tempered by the realization that its drug is not approved in the US, nor in Europe in the diabetic populations studied.
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.
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.