Japanese drug maker Takeda, Asia’s largest pharmaceutical company, and a major player in the global diabetes medication market, has ceased development of its type 2 drug, TAK-875 (fasiglifam).
The Osaka-based company said it stopped work on the drug, which its trials showed could be linked to liver damage. Takeda had asked three independent consultant panels to confirm its research before pulling the drug.
“The company has reached the conclusion that, on balance, the benefits of treating patients with fasiglifam do not outweigh the potential risks,” Takeda said in a report published in Bloomberg Technology. “Takeda is working with trial investigators and local regulatory authorities to ensure that patients who participated in the fasiglifam trials are transitioned to appropriate therapies.”
TAK-875 had already entered Phase 3 studies in Japan, the United States, and Europe when Takeda made the announcement.
The drug is the first in a new class of type 2 drugs called GPR40 (G Protein-Coupled Receptors) agonists. The drug works by countering the deleterious effects of fatty acids on pancreatic beta cells. By stimulating glucose-dependent insulin secretion, it lowers blood glucose levels.
The biggest promise Takeda held out for TAK-875 was that besides lowering A1c’s in a statistically significant way, the drug was associated with very little increase in the risk of hypoglycemia.
Takeda was hoping to introduce fasiglifam as an encore to Actos, its mainstay diabetes therapy that generated $3.7 billion in sales in 2011 and accounted for 27 percent of the company’s total revenue. In 2012, the drug began facing competition from generic versions, began cutting significantly into its revenue stream.
(Editor’s Note: Diabetes Health published a previous referenbce to TAK-875 in its September 17, 2013 report, “Type 2 Drugs in the Pipeline: an Update.” The article is available at http://www.diabeteshealth.com/read/2013/09/17/7992/type-2-drugs-in-the-pipeline-an-update/)