Takeda Re-Files DPP-4 Inhibitor Alogliptin, Plays Up Combo With Actos
This article was originally published in Pharmaceutical Approvals Monthly
As a means of differentiating its just-resubmitted diabetes drug alogliptin, Takeda Pharmaceutical Company Ltd. is playing up a fixed-dose combination with its blockbuster Actos, even though the latter drug has been hit hard by a potential link to bladder cancer.
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Takeda’s beleaguered Nesina (alogliptin) becomes the fourth DPP-4 inhibitor approved by FDA for diabetes; it remains to be seen whether the drug can find its place in a highly competitive space that continues to be controlled by Merck’s first-to-market blockbuster Januvia.
There is no statistical reason not to allow a single trial to provide pre-approval and post-approval cardiovascular hazard ratios for a diabetes drug, FDA says, but Janssen’s canagliflozin would be the first. The Endocrinologic and Metabolic Drugs Advisory Committee backed approval 10-5.
Latest “complete response” letter for Takeda’s DPP-4 inhibitor is “not specific” to cardiovascular outcomes. But the delay does not bode well for entry into the crowded DPP-4 space.