Takeda Stops Development of Oral Drug for Type 2 Diabetes Due to Liver Safety Concerns
On December 27, Takeda announced that it would stop development of TAK-875 (fasiglifam) due to liver safety concerns – this was one of the most unfortunate announcements we have heard in diabetes for a long time. The drug would have been the first in a new class of oral medications for type 2 diabetes called GPR40 agonists. The GPR40 agonist class has previously been billed as a “better sulfonylurea” because it improves glycemic control by stimulating insulin release, and without the higher risk of hypoglycemia often associated with sulfonylureas. For our last update on TAK-875, please read our new now next in diaTribe #34.
TAK-875 has been in late-stage patient trials in the US, Europe, and Japan, including a very large cardiovascular outcomes trial. Takeda reported early results for TAK-875 in May 2013 that showed greater A1c reductions compared to placebo (-0.75% for the 25 mg dose and -1.0% for the 50 mg dose) from an A1c baseline of around 7.8%. Little data have been shared about the liver safety issues and side effects of TAK-875, and it may be some time before the results are made public. We know that liver safety is extremely dangerous and the risk benefit ratio likely was not favorable enough for TAK-875 to move forward in the pipeline. This also comes at a time when an uncertain regulatory environment and increased competition in the field has raised the bar for advancing new therapies in diabetes. Nevertheless, it is very disappointing to hear that this new drug class will not be an option for patients anytime soon. –NL/JD/KC
