September will mark the beginning of a pivotal trial for Takeda's alogliptin, a diabetes drug the company hopes will replace its bestselling med Actos, when it goes off-patent. Takeda had hoped to gain approval of the drug before Actos's patents expired, but in June the FDA said it wouldn't approve alogliptin without a new clinical trial that fully explores the drug's cardiovascular effects. The agency enacted new cardiovascular safety guidelines issued in December that were retroactively applied to the drug candidate. And clinical data Takeda submitted didn't meet those new standards.
The FDA has agreed to Takeda's study design, which will enroll 5,400 patients at 1,000 sites in the U.S. "While this trial is dependent on the occurrence of CV events, at this point we anticipate that we will be able to submit interim results to the FDA approximately two years after the study begins that will meet the FDA Guidance criteria for drug approval," said Nancy Joseph-Ridge, M.D., General Manager, Pharmaceutical Development Division.
- here's Takeda's release
- read the Reuters article