Takeda Pharmaceuticals struggles to gain FDA approval
Takeda Pharmaceuticals determined to gain FDA drug approval
  • Mon, 05/14/2012 - 1:48pm

In a country bulging with 23 million people with type 2 diabetes, Avandia and its successor, Actos, were once blockbuster drugs in the U.S. after successfully lowering blood sugar levels in those diagnosed with the adult onset disease. Today, GlaxoSmithKline’s Avandia and Takeda’s Actos are viewed as dangerous drugs after being linked to side effects like increased risk of heart attack, congestive heart failure, and bladder cancer. Now Takeda awaits approval for a new diabetes drug, Nesina (alogliptin).

Takeda began working on Nesina in 2005 with Furiex Pharmaceuticals. In 2008, Takeda filed a new drug application with the FDA. However, that December, the FDA began requiring diabetes drug manufacturers to prove their medications wouldn’t increase diabetics’ already two- to fourfold risk of developing heart disease. Thus, in 2009, the FDA sent a letter to Takeda requesting information regarding Nesina’s cardiovascular safety. In 2011, Takeda resubmitted applications for both alogliptin and a combination therapy that includes Actos, which Japan approved in 2010 and markets as Liovel.

Nesina, the hoped successor to Actos, is part of a new class of drugs called dipeptidyl peptidase-4 inhibitors, which inhibit glucagon release, which increases insulin levels and decreases blood sugar levels. Despite Takeda recommending that Nesina be approved in conjunction with diet and exercise, the FDA has requested even more information before it makes a decision. Takeda has requested a meeting with the FDA to address any outstanding issues.

Actos lost patent rights in 2011, but generic drugs will hit the market later this year. Takeda continues to face a number of lawsuits. If you were injured while taking Actos, contact an experienced trial attorney today to review your case.

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