Memorandum

Forxiga approved in Japan – March 25, 2014

AstraZeneca announced Monday that its SGLT-2 inhibitor, Forxiga (dapagliflozin), has received regulatory approval in Japan. AZ will co-promote Forxiga in Japan with partner Ono Pharmaceuticals (as agreed upon in December 2013). Forxiga is the second SGLT-2 inhibitor approved in Japan, following Astellas/Kotobuki's Suglat (ipragliflozin), which was approved in January 2014. More potential competitors in Japan are not far behind - Taisho's luseogliflozin was submitted in April 2013 and J&J's Invokana (canagliflozin) in May 2013. As a reminder, Forxiga (known as Farxiga in the US) was the first SGLT-2 inhibitor to the global market, having been approved in Europe since November 2012 and in the US since January 2014. Global excitement continues to mount for the potential for an SGLT-2 inhibitor/DPP-4 inhibitor fixed-dose combination (FDC) therapy, and we are curious if such an FDC would be especially successful in Japan given the popularity of DPP-4 inhibitors in that region (purportedly, according to some, due to greater efficacy than in the global population).