FDA delays decision to update Lilly/BI’s Jardiance (empagliflozin) and Synjardy (empagliflozin/metformin) label by 90 days – August 15, 2016

As we understand it, the FDA will delay their decision on the indication expansion reflecting a cardiovascular mortality benefit for SGLT-2 inhibitor Jardiance (empagliflozin) and SGLT-2 inhibitor/metformin fixed-dose combination Synjardy (empagliflozin/metformin) for 90 days. The supplemental New Drug Application (sNDA) for the indicated was submitted on the basis of results from the EMPA-REG OUTCOME trial, which demonstrated an impressive 38% risk reduction for cardiovascular death and a significant 14% risk reduction in the three-point MACE primary outcome (non-fatal MI, non-fatal stroke, and CV death). A June 28th FDA Advisory Committee narrowly voted 12 - 11 vote in favor of the additional indication – our very own Ms. Helen Gao and Ms. Emily Regier spoke in favor of this expanded indication. We are hopeful that this delay is due to the unprecedented nature of the indication, and that the FDA will approve this label update at the end of the 90 days. We would be disappointed if the indication were not approved, as requiring companies to conduct these expensive and time-consuming studies and then not allowing the inclusion of positive findings in the label may discourage manufacturers from conducting ambitious trials aimed at demonstrating superiority, which can reveal important benefits that are important to for patients and providers to know about.


-- by Sarah Odeh, Helen Gao, and Kelly Close