Takeda defends Actos, in light of FDA committee meeting

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After two days of FDA advisory committee meetings focused on reviewing the cardiovascular safety of rosiglitazone (Avandia), Takeda Pharmaceuticals North America has underscored its position that pioglitazone HCI (Actos) offers an established safety profile regarding the risk of cardiovascular events in people living with type 2 diabetes.

Although drugs may be in the same class (thiazolidinedione) and have the same indication, they also may have different effects in other areas due to their specific structure, the Deerfield, Ill.-based company said.

“Takeda remains confident in the breadth, depth and consistency of Actos data,” according to the company’s press release, which pointed to its post-marketing study, PROactive. Actos studies, conducted over the past 11 years in more than 20,000 patients, show no evidence that Actos is associated with an increased risk of heart attack, stroke or death, Takeda said.