FDA approves inclusion of EMPA-REG OUTCOME data on the labels of Lilly/BI’s Synjardy (empagliflozin/metformin), Synjardy XR (empagliflozin/metformin extended-release), and Glyxambi (empagliflozin/linagliptin) – January 4, 2017

Late this afternoon, Lilly announced that the FDA has approved supplemental New Drug Applications (sNDAs) to include data from the landmark EMPA-REG OUTCOME trial on the labels of three additional BI-partnered medications: Synjardy (empagliflozin/metformin), newly-approved Synjardy XR (empagliflozin/metformin extended-release), and Glyxambi (empagliflozin/linagliptin). Notably, the data is included on the label but did not garner the expanded indication for cardiovascular death that was newly-added to the standalone Jardiance (empagliflozin) label in early December. That said, the inclusion of the data on the label is still a major win as it allows Lilly and BI to discuss the EMPA-REG OUTCOME data in marketing and promotion materials – and will likely afford these products some leverage in formulary negotiations. We’re also pleased to see the EMPA-REG OUTCOME data included on the Synjardy XR and Glyxambi labels – at the time of the data submission, Lilly only publicly shared that it was seeking the addition of the data to the Jardiance and Synjardy labels. It’s clear that much of Lilly’s diabetes strategy moving forward centers on promoting the Jardiance franchise through this unprecedented data and we hope that the company will begin to focus more resources on its combination products following this approval, as these products have much potential to improve patient outcomes with less pill burden.


-- by Abigail Dove, Helen Gao, and Kelly Close