US FDA Requests Additional Data on Takeda’s Alogliptin

Takeda Pharmaceuticals have suffered a key setback after US regulators rejected their type 2 diabetes therapy, alogliptin, and the fixed-dose combination of the medicine with Takeda’s Actos.

Actos lost patent protection in 2011, and generic versions of the drug are anticipated to hit the marketplace later this year.

The business received a second complete response letter from the US Food and Drug Administration (FDA) in response to the New Drug Applications for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor and the alogliptin/Actos (pioglitazone).

In the letter the FDA requested further data which Takeda is planning on supplying from post-marketing statistics from outside the USA, alongside data gained from their on-going clinical trial programme.

Approximately 26 million people in the United States have diabetes, with type 2 diabetes accounting for 90 – 95% of all cases, according to the American Diabetes Association.  Global healthcare costs to treat and prevent diabetes and its complications were predicted as $376 billion in 2010, Takeda noted.

Alogliptin belongs to a comparatively new class of diabetes medicines called DDP-4 inhibitors for the treatment of type 2 diabetes.  Dipeptidyl peptidase-4 inhibitors work by enhancing the body’s ability to lower elevated levels of blood sugar.

Thomas Harris, Takeda’s head of regulatory affairs at their R&D centre in the USA, commented that Takeda “will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues.”  He added that “we remain confident in the benefit that alogliptin will bring.”

Takeda previously resubmitted two New Drug Applications in July last year, after receiving the first complete response letter in June 2009, which contained interim data from a cardiovascular outcomes trial.  The filing for alogliptin was initially submitted in December 2007, a year prior to the FDA issuing fresh guidelines for diabetes drugs.

Alogliptin was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare, and is currently sold under the brand name Nesina.  The fixed-dose combination gained the green light in Japan in July 2011, and is available as Liovel.


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