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Takeda Official Says Alogliptin Faces Near Three-Year U.S. Delay

This article was originally published in PharmAsia News

Executive Summary

Takeda Pharmaceutical said a launch of its SYR-322 alogliptin diabetes drug would be delayed by nearly three years after U.S. FDA ordered new trials as a condition for approval. The agency told Takeda in March it would need more data on the drug, leading Takeda earlier this month to delay its plans to seek European approval until 2012. A Takeda public relations executive acknowledged the need to conduct more tests would delay U.S. approval until at least the end of the March, 2012, business year. (Click here for more
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