Two years after the FDA handed back Takeda's NDA for the diabetes drug alogliptin, the Japanese pharma company has come back and re-filed its application with interim cardiovascular safety data it believes can withstand a second round of regulatory scrutiny.
Back in 2009, the FDA dealt Takeda a heavy blow when regulators demanded a new safety study ahead of any approval. Takeda had to scrap its marketing plans for the blockbuster hopeful--a replacement for Actos, which is losing patent protection next year and earned $3.3 billion in 2010--and head back to the clinic.
Takeda resubmitted two NDAs for alogliptin--a DPP-4 inhibitor for Type 2 diabetes--and a combination treatment with pioglitazone in a single tablet. They'll be making their case with interim data from a study that won't deliver final results until 2014. But even back in 2009 Takeda officials were confident that they could come back this year with enough cardio data to win over the regulators.
"We believe interim results from a cardiovascular outcomes trial satisfy the FDA's cardiovascular safety requirements to allow the Agency to complete its review of our NDA, and further support the product profile of alogliptin," said Dr. David Recker, senior vice president, clinical science, Takeda Global Research & Development Center. "If approved, alogliptin/pioglitazone will be the first type 2 diabetes treatment option in the U.S. to include both a DPP-4 inhibitor and a thiazolidinedione in a single tablet."
- see the Takeda release