Astellas gains Japanese clearance for diabetes drug Suglat

Japanese drug major Astellas Pharma (TYO: 4503) has obtained the marketing approval of selective SGLT2 inhibitor Suglat tablets (ipragliflozin L-proline; development code: ASP1941) for the treatment of type 2 diabetes in Japan. Astellas filed an application for approval in March 2013.

Last year, Astellas signed a Japanese co-promotion deal with US pharma giant Merck & Co’s (NYSE: MRK) local subsidiary MSD KK (The Pharma Letter September 2, 2013). In what came as something of a surprise, in November 2012 Astellas decided to discontinue the US and European Phase II development of its ipragliflozin, citing purely commercial reasons.

Suglat is a selective SGLT2 (Sodium-Glucose Co-Transporter 2) inhibitor discovered through a research collaboration and is being jointly developed with Kotobuki Pharmaceutical. Suglat reduces blood glucose levels by inhibiting the reuptake of glucose by selectively inhibiting SGLT2. Suglat is the first SGLT2 inhibitor approved as a treatment for type 2 diabetes in Japan. The efficacy and safety of Suglat were observed in a Phase III pivotal study in monotherapy and clinical studies used in combination with other hypoglycemic agents (six types) in Japan.