Takeda's Alogliptin Suffers Major Setback, Delaying Drug Launch Until 2012 Or Later
This article was originally published in The Pink Sheet Daily
Negative news increases pressure on Japanese pharma's oncology subsidiary Millennium Pharmaceuticals to perform.
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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.
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.