Takeda/Teijin gain US OK for new gout drug

Takeda Pharmaceuticals North America, the US subsidiary of the like-named leading Japanese drugmaker, has received Food and Drug  Administration marketing approval for Uloric (febuxostat) for the  chronic management of hyperuricemia in patients with gout, the first new  agent cleared for this indication in 40 years.

Febuxostat was discovered by fellow Japanese company Teijin Pharma, and  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.

"This FDA approval granted to Takeda Pharmaceuticals North America,  along with the European Medicines Agency (EMEA) approval given last year  to Ipsen, our licensee for febuxostat in Europe, marks a significant  milestone for our global business," said Osamu Nishikawa, president of  Teijin. "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," he added.