Four months before Japan's Takeda will get hit with a tsunami of generic competition for the diabetes blockbuster Actos, the FDA has once again rebuffed the company's application to sell the experimental drug alogliptin. More than 5 years since it originally sought an approval, the drug giant says that the agency wants more data before it can issue an approval for the treatment, which was intended to replace Actos.
The move to re-file the drug was always considered something of a gamble. Takeda and its partner Furiex ($FURX) launched new studies after the treatment was turned down in 2009. Those trials won't be complete until 2014, though the companies had hoped that interim cardio data would suffice for an approval.
Takeda says those ongoing studies, along with data gathered in markets outside the U.S., should satisfy the regulators. "We will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues," said Takeda regulatory chief Thomas Harris in a statement. "We remain confident in the benefit that alogliptin will bring to patients with type 2 diabetes in the U.S., if approved."
The FDA has never been easy on diabetes drugs, and in recent years regulators have toughened up even more with demands for extensive safety data. Shares of Furiex plunged more than 20% on this latest setback.
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- here's the story from Bloomberg