February 22, 2021

Notification of Application for Approval of Manufacturing and Marketing for Orally Disintegrating Films of SGLT2 Inhibitor Lusefi® Tablets

Taisho Pharmaceutical Co., Ltd. (Head Office: Toshima-ku, Tokyo; Chief Executive Officer: Shigeru Uehara; “Taisho”) announced that today it submitted an application for approval of manufacturing and marketing for orally disintegrating films of SGLT2 inhibitor Lusefi® tablets (generic name: Luseogliflozin Hydrate; hereinafter “the drug") to the Ministry of Health, Labour and Welfare.

Lusefi® tablets, which was developed by Taisho, is a type of drug that excretes glucose in the urine and lowers blood glucose levels by selectively inhibiting sodium-glucose cotransporter 2 (SGLT2), which is responsible for renal tubular reabsorption of glucose. s were approved for manufacturing and marketing for the treatment of type 2 diabetes in March 2014, and was launched in May 2014.

Type 2 diabetes, which is a chronic disease, requires continuous treatment to prevent the onset and progression of complications, such as diabetic retinopathy and diabetic nephropathy, in addition to controlling hyperglycemic conditions from an early stage. However, one problem has been that many patients in the working generation refuse or discontinue treatment.

Because the shape of the drug is a thin sheet, it is less bulky and more portable than tablets. In addition, it dissolves quickly in the mouth with liquid, such as saliva, enabling patients to take the drug more easily. The drug is expected to contribute to the improvement of adherence* because it can be taken according to the patient's situation.

Taisho seeks to contribute to the treatment of diabetes by providing the drug together with Lusefi® tablets.

* Adherence: A patient's attitude toward actively participating in deciding on the treatment policy and receiving treatment according to the decision.