Takeda rebuffed (again) in long quest for FDA drug OK

Posted under Actos, alogliptin, Blog, Companies, Diabetes, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Takeda, Universities, Videos by john

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.  

- get the press release
- here's the story from Bloomberg

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FDA delays review of key Takeda diabetes drug, Actos combo

Posted under Actos, Blog, Companies, Diagnostics, FDA, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Takeda, Universities, Videos by Ryan McBride

Takeda Pharmaceuticals has been dealt another setback in its quest to gain U.S. approval of its diabetes drug alogliptin and a combo tablet that combines the developmental compound with the blockbuster diabetes pill Actos. The FDA has delayed review of the drugs, moving the action date for the Japanese drugmaker's applications for approval from Jan. 25 to April 25, the company said today.

Tokyo-based Takeda has a lot riding on alogliptin, a DPP-4 inhibitor intended to help patients with type 2 diabetes manage blood glucose levels. The drug is a potential successor to Actos, the company's best-selling drug that loses patent protection next year. If the FDA stamps an approval on the combo of the two drugs, according to Takeda, it would be the first U.S. therapy to combine a DPP-4 inhibitor and a treatment from the thiazolidinedione class to which Actos belongs in a single tablet. Japanese regulators approved alogliptin (Nesina) and the alogliptin-Actos combo (Liovel) last year and in July, respectively.

Actos brought in $4.3 billion in global sales last year and accounted for 51.8% of Takeda's U.S. sales.

U.S. regulators have proven to be a tough bunch to win over for Takeda. They denied approval of alogliptin in 2009, demanding additional data on the drug amid concerns about cardiovascular risks to patients on the treatment. When the company filed for approval this summer, it was confident that interim results from an ongoing study into the cardiovascular risks would be enough to satisfy the FDA.

"Takeda is confident in alogliptin and alogliptin/pioglitazone [Actos] as potential therapeutic options for the millions of patients living with type 2 diabetes," Dr. David Recker, senior vice president of clinical science for Takeda Global Research & Development Center, said in a statement. "We will work closely with the FDA to determine the appropriate next steps, and are dedicated to continuing our efforts to bring these important therapies to market in the U.S."

- here the company's release

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