Press Release
Approval of Suglat® Tablets, Selective SGLT2 Inhibitor,for Additional Indication of type 1 diabetes mellitus andAdditional dosage and administration in JapanTokyo, December 21, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO:Kenji Yasukawa, Ph.D., “Astellas” ) and Kotobuki Pharmaceutical Co., Ltd. (Presidentand 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 andthe additional dosage and administration has been obtained in Japan. Suglat® received
marketing approval for the indication of type 2 diabetes mellitus in January 2014 andhas 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 andreduces blood glucose levels.
Type 1 diabetes is a disease with insulin deficiency that occurs when the β cells in thepancreas, 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 newtreatment 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.

1

(1) Overview of “National Health and Nutrition Survey” Findings in 2016, Ministry of Health, Labour andWalfare.
(2) Japan Diabetes Complication and its Prevention (JDCP) Prospective Study 2015,
Product overview (with additional underlined areas)
Trade name
Generic nameIndication

Dosage and administration

Date of approval

Suglat® 25mg
Suglat® 50mg

Ipragliflozin L-Proline

Type 2 Diabetes mellitus
Type 1 Diabetes mellitus

Type 2 diabetes mellitus
For adults, the usual oral dosage is 50 mg as ipragliflozin once
daily before or after breakfast. In the case of inadequate
efficacy, the dose may be increased to 100 mg once daily
while careful monitoring of the patient’s conditions.
Type 1 diabetes mellitus
For adults, the usual oral dosage is 50 mg as ipragliflozin once
daily before or after breakfast, coadministered with insulin
prep-arations. In the case of inadequate efficacy, the dose
may be in-creased to 100 mg once daily while carefulmonitoring of the patient’s conditions.
December 21, 2018

About Astellas

Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people
around the world through the provision of innovative and reliable pharmaceutical products. For more
information, please visit our website at https://www.astellas.com/en
About Kotobuki

Kotobuki Pharmaceutical Co., Ltd., based in Nagano, Japan, is a company dedicates its efforts to researchand development of innovative drugs and to provide generic drugs. We put a priority onDiabetes/Nephrology, Gastroenterology, Dyslipidemia, Oncology and Immunology as focused therapeuticareas in our research. We continuously pursue high level of creativity in drug discovery, quality of products
and morality for contributing to higher level of quality of life and healthy life expectancy of patients.
For more information, please visit our website at https://ssl.kotobuki-pharm.co.jp/en/
Cautionary Notes (Astellas)

In this press release, statements made with respect to current plans, estimates, strategies and beliefs andother statements that are not historical facts are forward-looking statements about the future performanceof Astellas. These statements are based on management’s current assumptions and beliefs in light of theinformation currently available to it and involve known and unknown risks and uncertainties. A number offactors could cause actual results to differ materially from those discussed in the forward-lookingstatements. Such factors include, but are not limited to: (i) changes in general economic conditions andin laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii)2

delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively,(v) the inability of Astellas to continue to effectively research and develop products accepted by customers
in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development) which isincluded in this press release is not intended to constitute an advertisement or medical advice.
###Contacts for inquiries or additional information：
Astellas Pharma Inc.
Corporate Communications
TEL: +81-3-3244-3201 FAX: +81-3-5201-7473
Kotobuki Pharmaceutical Co., Ltd.
Corporate Communications
TEL: +81-268-82-2211 FAX: +81-268-82-2215

3