Takeda Pharmaceutical has received a complete response letter from the US Food and Drug Administration (FDA) regarding its new drug applications (NDAs) for alogliptin and the fixed-dose combination therapy alogliptin and pioglitazone.
Alogliptin is a DPP-4 inhibitor that is being investigated in the US, as an adjunct to diet and exercise, for the treatment of type 2 diabetes.
The FDA has requested Takeda to submit additional data, which the company plans to provide post-marketing data from outside the US, as well as data from its ongoing clinical trial program.
Furiex president and chief medical officer June Almenoff said the company is disappointed with the FDA decision.
"Our partner Takeda has extensive Phase III data, including interim findings from a cardiovascular outcomes trial and we remain confident in the future potential of alogliptin and alogliptin/pioglitazone for the treatment of type 2 diabetes," Almenoff added.
Currently, Furiex receives royalty payments from Takeda for the sale of alogliptin products, trade names Nesina and Liovel in Japan.
