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.
You may also be interested in...
Takeda Treads Carefully With DPP-4 Late-Arrival Nesina, Plans Summer Launch
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.
Use Of Pre-Approval CV Data From Ongoing Trial Gets Once-Over At Canagliflozin Panel
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.
Alogliptin Rejection Dents Takeda’s Diabetes Franchise
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.