Japan’s Takeda Pharmaceutical Company has resubmitted two new drug applications to the US Food and Drug Administration (FDA) for a type 2 diabetes medicine.
The drug manufacturer hopes that the FDA will approve alogliptin as a stand-alone treatment and as a single-pill therapy in combination with pioglitazone, a previously approved drug.
Alogliptin, designed to regulate blood glucose levels, was discovered by Takeda San Diego and rejected in June 2009 by the FDA, which said the company needed to conduct more tests.
Takeda now believes its interim results from a cardiovascular outcomes trial will satisfy the regulator’s safety requirements.
David Recker, managing director and senior vice-president for Clinical Science at Takeda Global Research & Development Center said, “If approved, alogliptin / pioglitazone will be the first type 2 diabetes treatment option in the US to include both a DPP-4 inhibitor and a thiazolidinedione in a single tablet.”
The company has conducted 12 phase III clinical trials of alogliptin involving 8,000 patients worldwide.
In these studies, alogliptin 25mg, taken once daily, demonstrated statistically significant reductions in haemoglobin A1c, which reflects average blood glucose concentration over the previous two to three months.
The common adverse events identified in this Phase III program include headache, urinary tract infection, nasopharyngitis and upper respiratory tract infection.
The FDA will review the resubmissions within the next six months.