Takeda Pharmaceuticals, manufacturers of the controversial diabetes drug Actos, yesterday re-submitted their application for FDA approval of their new drug, alogliptin.
In April of this year, the FDA rejected Takeda Pharmaceutical’s application, citing safety concerns and lack of information in clinical trials.
The resubmission includes more detailed evidence from new three new phase 3 clinical trials, with more than 3,000 patients. This data, combined with the previously-submitted data, reports on studies involving more than 10,000 patients world-wide.
Alogliptin has also met with success in Japan, where it is marketed as NESINA. There are currently no reported adverse effects, except for mild hypoglycemia, headache, urinary tract infection, upper respiratory infection and influenza in clinical studies.
David Recker, MD, senior VP of clinical science at Takeda, says, “Based on our meeting with the FDA in late June, Takeda believes the information included in the NDA resubmissions for alogliptin and the fixed-dose combination alogliptin and pioglitazone will address the Agency’s request for additional data, and these investigational therapies remain a top priority for the company.”
Takeda’s push for FDA approval of alogliptin comes in the midst of a slew of personal injury lawsuits concerning their successful but controversial drug, Actos, which has been linked to bladder cancer and heart disease in several studies. Despite concerns about the damaging side effects, Takeda continues to use pioglitazone (the generic name for Actos) in their diabetes drugs.
Lawsuits against Takeda Pharmaceuticals are combined under one multidistrict litigation in Louisiana, named MDL 2299, Judge Rebecca Doherty presiding.
If you or a loved one have Type 2 diabetes, were prescribed Actos to treat your condition, and now suffer complications including bladder cancer, heart disease, and macular edema, you may be entitled to compensation. The experienced attorneys at Strom Law, LLC, currently accept cases nationwide against Takeda Pharmaceuticals. Please contact us today for a free consultation. We can help get you on the road to recovery. 803.252.4800.