AZ's Xigduo (dapagliflozin/metformin) approved in Europe – January, 28, 2014

AZ recently announced that its fixed-dose combination (FDC) of the SGLT-2 inhibitor Forxiga (dapagliflozin) and metformin has been granted Marketing Authorization by the European Commission, making it the first SGLT-2 inhibitor/metformin FDC to receive regulatory approval. Xigduo will be available in two dosages, each consisting of 5 mg Forxiga and either 850 mg or 1000 mg of metformin. Given that metformin extended release (XR) is not available in Europe, these will be twice-daily tablets. AZ is also working on a once-daily dapagliflozin/metformin XR formulation to market in the US - it expects a regulatory decision from the FDA in 4Q14 for this formulation. When AZ announced its acquisition of BMS' diabetes business in December, AZ CEO Mr. Pascal Soriot remarked that fixed-dose combinations including Xigduo and the SGLT-2/DPP-4 inhibitor FDC "saxa/dapa" (saxagliptin/dapagliflozin; submission expected in 4Q14) are a major area of interest for the company moving forward (read our report on that presentation for more details). We were glad to hear Mr. Soriot's enthusiasm for FDCs, given their potential to reduce patient co-pays and improve adherence. J&J and Lilly also have late-stage SGLT-2/metformin FDCs in development. Lilly hopes to file empagliflozin/metformin in 2014. J&J received a Complete Response Letter from the FDA in December 2013 for its Invokana (canagliflozin)/metformin immediate release (IR) (see item #3 of our December 17, 2013 Letter). J&J also submitted an EMA Marketing Authorization Application (MAA) for canagliflozin/metformin IR in March 2013; placing potential approval in March 2014 with a standard review cycle. Finally, J&J also has an Invokana/metformin XR FDC currently in phase 3 development. We are very eager to watch FDC development in 2014; it will be fascinating to watch commercialization; we aren't sure how these compounds will affect profitability (some industry insiders are skeptical) but we certainly see them being more patient friendly - and thus, more HCP-friendly, and more payer-friendly, given the extent to which all these groups benefit from greater patient adherence.