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Approval of Suglat® Tablets, Selective SGLT2 Inhibitor, for Additional Indication of type 1 diabetes mellitus and Additional dosage and administration in Japan

10:00 EST 21 Dec 2018 | Astellas Pharma Inc.

Tokyo, December 21, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and Kotobuki Pharmaceutical Co., Ltd. (President and CEO; Hiroshi Tomiyama, “Kotobuki”) today announced that approval of selective SGLT2 inhibitor Suglat® Tablets (generic name: Ipragliflozin L-Proline , development code: ASP1941, "Suglat®") for the additional indication of type 1 diabetes mellitus and the additional dosage and administration has been obtained in Japan. Suglat® received marketing approval for the indication of type 2 diabetes mellitus in January 2014 and has been on the market since April 2014 in Japan.

Suglat® is a selective SGLT2 (Sodium-Glucose Co-transporter 2) inhibitor discovered through a research collaboration 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 proximal tubule of the kidneys. By selectively inhibiting SGLT2, Suglat® suppresses the reuptake of glucose and reduces blood glucose levels.

Type 1 diabetes 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 diabetes1. It was estimated that type 1 diabetes account for around 6% of patients with diabetes2

Astellas will continue contributing to the treatment of diabetes through providing new treatment options for patients with type 1 diabetes mellitus who have inadequate glycemic control with insulin.

Astellas reflected the impact from this launch in its financial forecasts of the current fiscal year ending March 31, 2019.

Original Article: Approval of Suglat® Tablets, Selective SGLT2 Inhibitor, for Additional Indication of type 1 diabetes mellitus and Additional dosage and administration in Japan

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