Memorandum
J&J announced Friday that the European Commission has approved its SGLT-2 inhibitor/metformin fixed-dose combination Vokanamet (Invokana/metformin IR), making it the second such FDC to the market. This decision follows the positive CHMP opinion that J&J received in February and also follows the recent European approval of competitor AstraZeneca’s Xigduo (Forxiga/metformin IR fixed-dose combination) in January 2014. In the US, Vokanamet was recently re-submitted to the FDA (as announced by J&J during its 1Q14 financial update). As a reminder, the FDA issued a CRL for Vokanamet in November requesting additional data demonstrating that the twice-daily dosing regimen of Vokanamet was comparable to that of the once-daily dosing of the approved Invokana single agent (since metformin immediate release [IR] is a twice-daily therapy, Invokana/metformin IR FDC must be dosed as a twice-daily combination). J&J is also working on an Invokana/metformin extended release (XR) FDC that would allow for once-daily dosing; that agent remains in phase 3. We are excited about combination therapy; very few patients are controlled on metformin alone, and ultimately the vast majority need two and three drugs and more as their disease progresses. A recent New York Times article, in fact, misses the point about metformin vs. GLP-1. Sole focus on cost misses the real world point for most patients, who need metformin as well as other therapy – we look forward to more combinations with metformin and other branded drugs.