Takeda’s Zafatek approved for type 2 diabetes in Japan

The Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application of Zafatek (trelagliptin succinate), a drug for treating type 2 diabetes from Takeda Pharmaceutical (TYO: 4502), Japan’s largest drugmaker.

Zafatek is a once-weekly DPP-4 (dipeptidyl peptidase-IV) inhibitor. It controls blood glucose levels by selectively and continually inhibiting DPP-4, an enzyme that causes the inactivation of glucagon-like peptide-1 and glucagon-dependent insulinotropic polypeptide, incretin hormones* that play an important role in blood glucose regulation. The inhibition of DPP-4 increases insulin secretion depending on blood glucose concentration, thereby controlling blood glucose levels.

Under an agreement with Furiex Pharmaceuticals, acquired by Forest Labs in 2014, which was itself acquired by Actavis (NYSE: ACT) later that year, the US firm was eligible to receive royalties and sales-based milestones from Takeda if trelagliptin succinate is approved and marketed in Japan.

Clinical backing

The approval granted is based on the safety and efficacy results of multiple clinical Phase III 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.

Takeda expects that it can provide a new treatment option with Zafatek, the world's first once-weekly DPP-4 inhibitor, and contribute to improvement in drug adherence and continued treatment of patients. The approval granted is a very important milestone for Takeda, the company stated.