Notification of Application for Additional Dosage Form of SGLT2 inhibitor CANAGLU® OD Tablets 100 mg
March 20, 2023
Today, Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative Director: Hiroaki Ueno; hereafter, “MTPC”), a member of the Mitsubishi Chemical Group, submitted to the Ministry of Health, Labour and Welfare an application for an additional dosage form of orally disintegrating (OD) tablets for SGLT2 inhibitor CANAGLU® Tablets 100 mg (generic name: Canagliflozin Hydrate).
Canagliflozin promotes the excretion of excessive glucose into the urine, and as a result, lowers the blood glucose level. In addition, Canagliflozin is presumed to exhibit a renoprotective effect by reducing glomerular pressure in the kidney, etc.
CANAGLU®, discovered by MTPC, was approved in July 2014 in Japan as a treatment agent for type 2 diabetes mellitus and was launched in September 2014. In June 2022, it obtained approval for the treatment of chronic kidney disease complicated with type 2 diabetes mellitus (excluding patients with end-stage renal disease or undergoing dialysis).
Since OD tablets disintegrate easily with a small amount of water, they are easy to take for patients with impaired swallowing function who have difficulty swallowing tablets, patients who are careful about fluid intake, and elderly people. Furthermore, since the drug can be taken without water by saliva in the mouth, it can be taken regularly without being restricted to places, and it is expected to improve the adherence of patients with type 2 diabetes mellitus or chronic kidney disease complicated by type 2 diabetes mellitus who need continuous treatment and to continue taking the drug.
MTPC has TENELIA®, a selective DPP-4 inhibitor, as well as CANALIA®, which are a combination of TENELIA® and CANAGLU®, as medications for type 2 diabetes mellitus. In June 2021, it launched OD tablets for TENELIA®. TENELIA® OD Tablets is the only selective DPP-4 inhibitor OD tablets in Japan at present.
Mitsubishi Tanabe Pharma will continue working to deliver the new treatment options for people living with type 2 diabetes to enhance satisfaction with treatment and convenience.
Canagliflozin promotes the excretion of excessive glucose into the urine, and as a result, lowers the blood glucose level. In addition, Canagliflozin is presumed to exhibit a renoprotective effect by reducing glomerular pressure in the kidney, etc.
CANAGLU®, discovered by MTPC, was approved in July 2014 in Japan as a treatment agent for type 2 diabetes mellitus and was launched in September 2014. In June 2022, it obtained approval for the treatment of chronic kidney disease complicated with type 2 diabetes mellitus (excluding patients with end-stage renal disease or undergoing dialysis).
Since OD tablets disintegrate easily with a small amount of water, they are easy to take for patients with impaired swallowing function who have difficulty swallowing tablets, patients who are careful about fluid intake, and elderly people. Furthermore, since the drug can be taken without water by saliva in the mouth, it can be taken regularly without being restricted to places, and it is expected to improve the adherence of patients with type 2 diabetes mellitus or chronic kidney disease complicated by type 2 diabetes mellitus who need continuous treatment and to continue taking the drug.
MTPC has TENELIA®, a selective DPP-4 inhibitor, as well as CANALIA®, which are a combination of TENELIA® and CANAGLU®, as medications for type 2 diabetes mellitus. In June 2021, it launched OD tablets for TENELIA®. TENELIA® OD Tablets is the only selective DPP-4 inhibitor OD tablets in Japan at present.
Mitsubishi Tanabe Pharma will continue working to deliver the new treatment options for people living with type 2 diabetes to enhance satisfaction with treatment and convenience.
