AstraZeneca's Farxiga Gets CRL from FDA for Type I Diabetes
The company will meet with the FDA to discuss the CRL and seek the path forward for the sNDA. Please note that, in March, the FDA also issued a CRL to Lexicon Pharmaceuticals, Inc.’s LXRX new drug application seeking approval for Zynquista, a dual SGLT1 and SGLT2 inhibitor, in combination with insulin as a treatment for type I diabetes. There is no approved SGLT inhibitor for type I diabetes in the United States. AstraZeneca’s stock has increased 5.8% this year so far, outperforming the industry’s decrease of 1.6%. Other SGLT2 inhibitors available in the market are Johnson & Johnson’s JNJ Invokana and Lilly’s Jardiance, Synjardy (a fixed dose combination of Jardiance and metformin) and Glyxambi (a fixed dose combination of Jardiance and Tradjenta). AstraZeneca PLC Price. AstraZeneca PLC price | AstraZeneca PLC Quote.