Astellas Pharma : Submits Supplemental New Drug Application for Approval of Additional Indication of Selective SGLT2 Inhibitor Ipragliflozin L-Proline for Patients with Type 1 Diabetes Mellitus in Japan

Tokyo and City, January 11, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, 'Astellas' ) and Kotobuki Pharmaceutical Co., Ltd. (President and CEO; Hiroshi Tomiyama, 'Kotobuki') today announced that Astellas submitted an application for the additional indication of the selective SGLT2 inhibitor Ipragliflozin L-Proline (generic name, brand name: 'Suglat Tablets, development code: ASP1941, 'Ipragliflozin') for the treatment of type 1 diabetes mellitus in Japan.

Type 1 diabetes mellitus is a disease with insulin deficiency that occurs when the β cells in the pancreas, which secrete insulin, are destroyed through immune system. It has been estimated that around 10 million people in Japan are very likely to have diabetes. It was estimated that type 1 diabetes mellitus account for around 6% of patients with diabetes.

Ipragliflozin is a selective SGLT2 (Sodium-Glucose Co-transporter 2) inhibitor discovered through a research collaboration and is being jointly developed with Kotobuki. SGLTs are membrane proteins exist on the cell surface and transfer glucose into cells. SGLT2 is one subtype of SGLTs that plays a key role in the reuptake of glucose in the the proximal tubule of the kidneys. By selectively inhibiting SGLT2, Ipragliflozin suppresses the reuptake of glucose and reduces blood glucose levels.

Ipragliflozin received marketing approval for the indication of type 2 diabetes under the brand name Suglat Tablets in January 2014 and has been on the market since April 2014.

Through the application for the indication, Astellas expects to provide a new treatment option for patients with type 1 diabetes mellitus whose glycemic control is inadequate and enhance its contribution to the treatment of diabetes.

The submission of the application for an approval has no impact on Astellas' consolidated financial forecasts for the fiscal year 2017 ending March 31, 2018.