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GEN News Highlights : Dec 27, 2013

Liver Problems Take Down Takeda Drug

Takeda Pharmaceutical reports that it is terminating the development activities for fasiglifam (TAK-875), an investigational treatment for type 2 diabetes due to concerns about liver safety. Just this past May, Takeda reported positive Phase III clinical trial results for the product. Once-daily administration demonstrated “statistically significant and clinically relevant HbA1c [a lab test that shows the degree to which diabetes is being controlled] lowering effect in type 2 diabetes patients.”

However, the company says it has worked with three independent panels of experts to provide for the safety of trial participants and ensure independent safety oversight for the clinical trials throughout the duration of the TAK-875 Phase III development program. One of these panels, the independent Liver Safety Evaluation Committee (LSEC), is comprised of five hepatologists with expertise in drug-induced liver injury. While remaining blinded to treatment information, the LSEC regularly evaluates data on liver enzymes elevations and adjudicates cases that impacted the liver. In addition, an independent Executive Committee (EC) provides additional oversight for the TAK-875 cardiovascular outcomes trial.

After careful consideration of the data emerging from all the clinical trials and in consultation with these panels, Takeda officials came to the conclusion that the benefits of treating patients with TAK-875 do not outweigh the potential risks.