Alogliptin delayed due to lack of FDA resources

The US Food and Drug Administration says the review of the New Drug Application of Takeda's type 2 diabetes drug alogliptin will be delayed beyond the action data, due to internal resource constraints.

The Japanese drug major noted that the FDA did not provide any guidance on when a review might be completed nor did it raise any issues with the data in the NDA itself. "Takeda remains confident in alogliptin's potential as a new treatment option for people suffering from type 2 diabetes and we will work with the FDA as they continue this NDA review," said Dean Sundberg, senior vice president, regulatory affairs at Takeda Global R&D Center.

Alogliptin's approval is important for Takeda as it will help the firm replace revenue lost when its blockbuster antidiabetic Actos (pioglitazone) - which contributes almost a third of total group turnover - loses patent protection in 2011.