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AstraZenecas Farxiga follows rival Zynquista to FDA rejection in Type 1 diabetes.

July 15, 2019 / Carly Helfand
SHARESHARESHARE

Turns out, the FDAs March rejection of Sanofi and Lexicon Pharmaceuticals Zynquista was just a preview of what would come for the SGLT class in Type 1 diabetes. The agency shot down a second drug from the group, AstraZeneca’s Farxiga, the British drugmaker said Monday. Regulators issued a complete response letter for the drug as an add-on to insulin in Type 1 adults whose insulin therapy isn't enough to control their blood sugar levels. AstraZeneca didn’t provide any details about the denial or a timeline for resubmitting its application, saying only that it would work closely with the FDA to discuss next steps. The FDA’s decision is hardly a shocking one, despite a thumbs-up for Farxiga—called Forxiga in Europe—from regulators across the pond earlier this year. The European Commission greenlighted the drug in overweight Type 1 patients, and an AstraZeneca spokesperson said at the time that “We remain confident in the positive benefit-risk profil...