Teijin Pharma and Takeda Pharmaceutical Company have announced that Teijin Pharma’s US licensee for febuxostat and Takeda’s wholly owned subsidiary, Takeda Pharmaceuticals North America, has received the FDA’s marketing approval for Uloric for the chronic management of hyperuricemia in patients with gout.
According to Teijin Pharma, febuxostat is an oral, once-daily, novel highly potent non-purine selective inhibitor of xanthine oxidase, having a structure completely different from that of the currently available xanthine oxidase inhibitor, which was developed over 40 years ago.
Febuxostat lowers the level of uric acid in the blood of hyperuricemic patients with gout, with clinical data supporting its safety and efficacy. In addition, febuxostat’s safety profile does not require dose adjustment for patients with mild-to-moderate renal or hepatic impairment, the company said.
Osamu Nishikawa, president of Teijin Pharma, said: This FDA approval granted to Takeda Pharmaceuticals North America, along with the EMEA (European Medicines Agency) approval given last year to Ipsen, our licensee for febuxostat in Europe, marks a significant milestone for our global business.
As to Japan and other areas including Asia, we are proceeding with our plans to develop febuxostat by ourselves as well as by collaborating with other companies. We will continue to strengthen our global operations by expanding areas where febuxostat is available and increase the presence of the product to be widely used by patients worldwide.