J&J recently updated the Invokana patient and HCP websites to reflect the recent approval of the Invokana CV indication, i.e., reduction of 3P-MACE from CANVAS/R (previous FENIX insight). Of note, this is the first OAD drug to receive an indication for 3P-MACE risk reduction. Below, FENIX provides additional details on messaging across the SGLT2i class. The updated Invokana patient website indicates that “Invokana is the only type 2 diabetes pill approved to help lower your A1C and reduce the risk of major cardiovascular events including heart attack, stroke, CV death.” The updated promotion depicting a male character doing a heart sign also seems to be new…….

Results from the Farxiga CVOT, DECLARE, were presented at the American Heart Association conference (AstraZeneca press release) along with a simultaneous publication in the NEJM. Below, FENIX provides thoughts on the many market implications. DECLARE Initial Takeaways and Potential Implications  (In no particular order…) The DECLARE 17% RRR in the composite primary endpoint could be viewed as somewhat underwhelming since there was no CV death benefit, unlike EMPA-REG’s 38% RRR in CV death. Perhaps, though, the 27% RRR in hHF in DECLARE is in the ballpark of RRR based on EMPA-REG and CANVAS/R hHF sub-analyses. At first glance, the DECLARE indication……