Takeda To Start New Alogliptin Trial In U.S. To Meet FDA Requirement
This article was originally published in PharmAsia News
Executive Summary
Takeda Pharmaceutical says it has decided to conduct another clinical trial in the United States for its SYR-322 (alogliptin) diabetes drug. U.S. FDA told Takeda in June it would need additional trials before it could approve the drug for treating Type 2 diabetes. FDA said it was not satisfied with the data provided by Takeda to show the drug met cardiovascular safety requirements. Takeda plans to begin the new trial in September with expectations the drug could reach the U.S. market early in 2012. (Click here for more - a subscription may be required
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