Takeda files for diabetes drug trelagliptin succinate approval in Japan

Takeda Pharmaceutical (TYO: 4502), Japan’s largest drugmaker, has submitted a New Drug Application to the Japanese Ministry of Health, Labor and Welfare for trelagliptin succinate (SYR-472), a once weekly dosage treatment for type 2 diabetes.

Under an agreement with Furiex Pharmaceuticals (Nasdaq: FURX), the US firm is eligible to receive royalties and sales-based milestones from Takeda if trelagliptin succinate is approved and marketed in Japan.

Takeda’s NDA is based on the safety and efficacy results of multiple Phase III clinical studies in patients with type 2 diabetes in Japan. The efficacy of once-weekly trelagliptin succinate was confirmed in all studies, in addition to a good safety and tolerability profile. Trelagliptin succinate controls blood glucose levels effectively with single weekly dosing, and is expected to contribute to improvement in drug adherence of patients.