Furiex Pharmaceuticals (Nasdaq: FURX) is going to have to wait longer to begin selling a type 2 diabetes drug in the U.S.
The Morrisville-based company, which once was part of Wilmington-based PPD, said Thursday that the U.S. FDA wants more data about the proposed drug Alogliptin from its Japanese partner Takeda.
The “complete response letter” from the FDA came after the submission of a new drug application for Alogliptin and another for a fixed-dose combination of Alogliptin and another compound called Pioglitazone.
“We are disappointed with the FDA decision,” said June Almenoff, president and chief medical officer of Furiex, in a statement. “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.”
Takeda “intends to immediately request a meeting with the FDA to determine the appropriate next steps and is committed to addressing outstanding issues,” Furiex noted in a statement.
Furiex already receives royalties from sales of two Alogliptin products in japan.
