Takeda's gout drug febuxostat headed for US FDA panel
This article was originally published in Scrip
Executive Summary
Takeda's NDA for the gout treatment Uloric (febuxostat) will be the focus of a November 24th review by the US FDA's arthritis advisory panel. The proposed indication is treatment of hyperuricaemia in patients with gout. This will be the third go-around in the US for the oral selective xanthine oxidase inhibitor, which has been the subject of two previous approvable letters from the FDA. The compound is licensed from Japan's Teijin Pharma, and Takeda gained the US rights through the unwinding of its TAP Pharmaceuticals joint venture with Abbott.