AsianScientist (Dec. 31, 2013) – Takeda Pharmaceutical Company Limited has decided voluntarily to terminate the development activities for fasiglifam (TAK-875), an investigational treatment for type II diabetes, due to concerns about liver safety.
The company has worked with three independent panels of experts throughout the duration of the fasiglifam (TAK-875) Phase III development program. The expert panels include the independent Data Monitoring Committee (DMC), which reviews the unblinded clinical data from fasiglifam trials and provides continual safety oversight of trial subjects and recommendations.
After considering the data emerging from all the clinical trials and in consultation with these panels, Takeda says that the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks.
According to the press release, Takeda is in communication with trial investigators and the relevant regulatory authorities regarding its decision. It is also working with trial investigators and local regulatory authorities to ensure that patients who participated in the trials are transitioned to appropriate therapies and that trial participants receive appropriate care.
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Source: Takeda Pharmaceutical Company.
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