Takeda ends development of diabetes drug fasiglifam due to concerns about liver safety
Takeda has decided to terminate the development of the experimental drug fasiglifam (TAK-875) for the treatment of patients with type 2 diabetes due to concerns about liver safety. Fasiglifam is a GPR40 agonist that was being tested in a phase 3 development program.
After reviewing of the data emerging from all the clinical studies in the fasiglifam phase 3 deveopment program, and consultations with three independent expert panels, including the data monitoring committee, Takeda concluded that the benefits of treating patients with fasiglifam do not outweigh the potential risks.
Takeda is in communication with trial investigators and the relevant regulatory authorities regarding the company’s decision, to provide them with updated and current information in compliance with local regulations. Takeda is working with trial investigators and local regulatory authorities to ensure that patients who participated in the fasiglifam (TAK-875) trials are transitioned to appropriate therapies and ensure that trial participants receive appropriate care.
Takeda press release, 27 December, 2013