Takeda submits new drug application for type 2 diabetes drug in Japan

Furiex Pharmaceuticals, under its agreement with Takeda, is eligible to receive royalties and sales-based milestones if trelagliptin succinate is approved and marketed in Japan.

Takeda Pharmaceutical has submitted the new drug application based on the safety and efficacy results of multiple Phase III clinical studies in patients with type 2 diabetes in Japan. In addition to a good safety and tolerability profile, trelagliptin succinate has confirmed efficacy in all studies.

Furiex chairman Dr Fred Eshelman noted the company is pleased that Takeda has taken this important step in seeking approval of trelagliptin succinate in Japan.

"This is a significant achievement for Furiex and Takeda’s type 2 diabetes franchise," Dr Eshelman added.

Furiex president and chief medical officer Dr June Almenoff said: "We are excited about the potential for trelagliptin succinate to provide type 2 diabetes patients with a convenient, once-weekly treatment option."

With single weekly dosing, Trelagliptin succinate controls blood glucose levels effectively and is expected to contribute to improvement in drug adherence of patients.

Takeda California, a wholly-owned subsidiary of Takeda Pharmaceutical, has discovered trelagliptin succinate, a once-weekly dipeptidyl peptidase-IV (DPP-4) inhibitor. By selectively and continually inhibiting DPP-4, the drug controls blood glucose levels.

DPP-4 is 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. DPP-4 inhibition increases insulin secretion depending on blood glucose concentration, thereby controlling blood glucose levels.