Mitsubishi Tanabe Pharma gets approval for Canalia combination tablets in Japan


Japanese firm Mitsubishi Tanabe Pharma’s combination drug application has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the manufacturing and sale of Canalia combination tablets for the treatment of an indication of type 2 diabetes mellitus.

Canalia is treatment agent that combines selective DPP-4 inhibitor Tenelia tablets (teneligliptin) and SGLT2 inhibitor Canaglu tablets (canagliflozin).

In 2012, Mitsubishi Tanabe Pharma formed a strategic sales alliance with Japanese pharmaceutical company Daiichi Sankyo to carry out joint sales activities for the DPP-4 and SGLT2 inhibitors.

The Tenelia and Canaglu tablets were originally discovered and developed by Mitsubishi Tanabe Pharma in Japan.

The marketing of Tenelia tablets is currently carried out by Daiichi Sankyo, whereas the Canaglu tablets are marketed by Mitsubishi Tanabe Pharma.

"Canalia tablets administered to patients with type 2 diabetes mellitus and whose blood glucose levels are stably controlled by concomitant treatment with Tenelia and Canaglu tablets, showed an enhanced convenience and medication adherence."

Canalia tablets can be orally administered once a day to the patient to reduce blood-glucose levels based on two different mechanisms of action - inhibiting DPP-4 to increase insulin release according to blood glucose levels and inhibiting SGLT2, promoting excretion of glucose into the urine.

Clinical trials conducted on type 2 diabetes mellitus demonstrated efficacy, safety and good tolerability of Canalia treatment on the Japanese patients who have inadequate glycemic control with the other two tablets.

In addition, Canalia tablets administered to patients with type 2 diabetes mellitus and whose blood glucose levels are stably controlled by concomitant treatment with Tenelia and Canaglu tablets, showed an enhanced convenience and medication adherence.

The use of the combination drug on type 2 diabetes mellitus patients who have inadequate glycemic control to monotherapy with Tenelia tablets or Canaglu tablets is also expected to improve the blood glucose control.

While commercialisation of Canalia will be carried out by Daiichi Sankyo, the combination tablets will be co-promoted by both the companies.