Astellas/Kotobuki's ipragliflozin approved in Japan – January, 28, 2014

Astellas recently announced that its SGLT-2 inhibitor ipragliflozin (brand name Suglat) was approved by Japanese regulatory authorities, making it the first SGLT-2 inhibitor to the Japanese market. The drug was developed in collaboration with Kotobuki Pharmaceutical, and in September the companies entered a Japanese co-promotion agreement with Merck (read our report). Merck is co-developing another SGLT-2 inhibitor, ertugliflozin, with Pfizer - the partnership covers all geographies except for Japan. Although ipragliflozin has the advantage of being first to market in Japan, its potential competitors are not far behind: AZ/Ono Pharmaceuticals' dapagliflozin, Taisho's luseogliflozin, and J&J/Mitsubishi Tanabe/Daiichi Sankyo's canagliflozin are all under regulatory review in Japan (submitted in March, April, and May 2013, respectively). As announced during Astellas F2Q12 update, the company does not plan to submit ipragliflozin in the US or EU due to the many options in the SGLT-2 field. This new wave of SGLT-2 inhibitors could mean more stress for manufacturers of DPP-4 inhibitors, which, to date, have been particularly popular in Japan. We learned during J&J's recent 4Q13 update that Invokana (the first SGLT-2 inhibitor in the US) has seen relatively strong uptake in the US, and will be interested to see if the broader SGLT-2 inhibitor class sees success in Japan as well.