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news.Takeda Pharmaceutical has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the new drug application (NDA) of Zafatek, a once-weekly DPP-4 (dipeptidyl peptidase-IV) inhibitor, for the treatment of people with type 2 diabetes.
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Zafatek (trelagliptin succinate) 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 a major role in blood glucose regulation.
The company said that the inhibition of DPP-4 increases insulin secretion depending on blood glucose concentration, thereby controlling blood glucose levels.
The approval is based on the safety and efficacy data from multiple clinical Phase III trials in patients with type 2 diabetes in Japan.
In addition to a good safety and tolerability profile, the efficacy of once-weekly trelagliptin succinate was also confirmed in all studies.
The company expects that it can provide a new treatment option with Zafatek and contribute to improvement in drug adherence and continued treatment of patients.