Furiex Pharmaceuticals said Takeda Global Research & Development Center has resubmitted New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for alogliptin and fixed-dose combination therapy alogliptin and pioglitazone for the treatment of type 2 diabetes in adults.
The resubmission of NDAs is in response to a complete response letter received by Takeda from the FDA on 25 April 2012.
The resubmissions include additional data from three phase III clinical trials involving more than 3,275 patients conducted at 1,384 centers worldwide.
Furiex chairman Fred Eshelman said Furiex is pleased that Takeda has taken the step of resubmitting the alogliptin NDA.
''These resubmissions are significant advancement towards regulatory approval of the alogliptin monotherapy," Eshelman added.
Furiex president and chief medical officer June Almenoff said, ''From the onset we have believed in the potential of alogliptin, if approved, to contribute to improving the health of diabetes patients, and these NDA resubmissions are important steps in expanding these treatment options to a wider patient population."
As part of the Furiex agreement with Takeda, Furiex will be eligible to receive a $25m milestone payment for the approval of the first of these two NDAs, as well as potential royalties and sales-based milestones.
Furiex currently receives royalty payments from Takeda for the sale of these alogliptin products in Japan, trade named as Nesina and Liovel.