DEERFIELD, Illinois –The U.S. Food & Drug Administration has sent Takeda Pharmaceuticals back to gather more data on its diabetes drug alogliptin, a setback for the Japanese company that will likely delay the drug for another two years.
Alogliptin is one of the most important drugs for Takeda, which has its North American headquarters in Illinois. The patent for its top-selling drug, Actos, expires in 2011 and alogliptin is thought to be the successor, according to Reuters.
Takeda stated in its release that the FDA didn’t think clinical data about the drug were enough to address concerns about cardiovascular side effects that have become an increasing issue in diabetes treatments. The FDA issued new guidance on cardiovascular programs in December 2008. Drugmakers hoped that those guidelines wouldn’t apply to applications submitted before the guidance. Apparently, they were wrong.
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