Takeda confirmed today that the FDA won't approve its critically important diabetes drug alogliptin without a new clinical trial that fully explores the drug's cardiovascular effects. A spokesman for the company told Bloomberg that the application for the Type 2 diabetes therapy could be resubmitted in two years, after a new trial is completed.
While a number of analysts had predicted a lengthy delay, noting the agency's new and tougher safety standards for diabetes drugs, the decision was a heavy blow for Takeda. The Japanese company had hoped to start marketing the once daily alogliptin, or SYR-322, as its existing drug, Actos, lost patent protection. Earlier this month Takeda announced that it was delaying its European application for alogliptin as it pursues new studies. A new application for Europe is expected in 2012.
"SYR-322 is the most important drug development agenda for Takeda," company spokesman Hisashi Tokinoya told Bloomberg. "We expect to lose patent protection on Actos, and with the decision by the FDA it's difficult to have the drug in time for the patent expiration.''