Top 5 Clinical Setbacks of 2014: Takeda’s fasiglifam.
The penultimate clinical study setback included in SCRIP and Datamonitor Healthcare’s top 5 clinical setbacks of 2014, focuses on metabolic.
It hasn’t been a bad year all-round for metabolic-focused therapies, so we have had to stretch back a bit for this inclusion on the list of trial failures. Right at the end of 2013, Takeda Pharmaceutical was forced to drop development of its diabetes compound fasiglifam (TAK-875) due to safety concerns, affecting the firm’s diabetes franchise into 2014.
The Japanese major announced that it had “decided voluntarily to terminate the development activities” for the molecule, which was in an international Phase III clinical program for type 2 diabetes in 450 patients across sites in the US, Europe and Japan.
The step was taken after reviewing the data in consultation with the three independent safety panels and external experts which led it to conclude that the benefits of fasiglifam did not outweigh the potential risks. Takeda did not elucidate the specific safety issues, saying only that “concerns about liver safety” were behind the decision.
Datamonitor analyst Rajan Sharma said fasiglifam’s failure leaves Takeda with limited presence in type 2 diabetes. “It was previously a relatively lucrative market before Actos lost patent protection,” he said.
Fasiglifam had been most advanced GPR40 agonist in development.
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