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FDA Rejects Actos-Based Drug for the 2nd Time

In April of this year, the FDA rejected Takeda Pharmaceuticals’ Actos style new drug, called alogliptin, citing a lack of data regarding the drug’s side effects.

Takeda Pharmaceuticals has been under fire in the last two years from patients who claim their drugs, specifically Avandia and Actos, cause severe side effects, and that Takeda knew about the medical problems associated with their drugs. Studies have linked Avandia and Actos to increased heart problems, and Actos specifically has been linked to bladder cancer and diabetic macular edema.

Takeda first sought approval for alogliptin since 2007, but the drug was first rejected by the FDA in 2009, citing similar concerns.

Thomas Harris, VP of Regulatory Affairs for Takeda Global Research & Development Center, released the following statement in response: “We will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues … We remain confident in the benefit that alogliptin will bring to patients with type 2 diabetes in the U.S., if approved.”

Alogliptin has already been approved for use in some countries, including Japan. Marketed as Nesina, Takeda Pharmaceuticals hopes data from the drug’s use in Japan, along with some ongoing studies, will satisfy the FDA. Actos, the company’s most successful yet most maligned diabetes drug, lost patent protection in 2011 and generic versions will hit the market in the next several months. Takeda hopes to replace Actos before competition becomes too tough.

Takeda Pharmaceuticals currently faces thousands of lawsuits, which have been consolidated into Multidistrict Litigation 2299, in Louisiana. The Honorable Rebecca Doherty is presiding judge. Plaintiffs can file directly with the Western US District Court of Louisiana (Lafayette).

If you live in South Carolina, and you or a loved one have been diagnosed with bladder cancer, heart problems, or liver failure as a result of taking Actos, please contact the experienced professionals at Strom Lawfirm, LLC. Our lawyers can help get you the compensation you deserve for your dangerous drug claim. 803.252.4800



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