Takeda and partner Teijin Pharma are celebrating the news that US regulators have given the go-ahead to Uloric for the chronic management of hyperuricaemia in patients with gout.

Takeda noted that Uloric (febuxostat), a once-daily, oral drug, “is the first new treatment option in more than 40 years for the more than five million patients who have hyperuricaemia associated with gout”. The approval was expected, seeing as it was recommended in November by the US Food and Drug Administration's Arthritis Advisory Committee by a vote of 12-0 with one panel member abstaining.

However the agency had missed a Prescription Drug User Fee Act date of January 18, citing its “inability to complete routine inspections at investigator sites” and at a clinical research organisation involved in the development of febuxostat. It has taken the FDA over four years to review the drug and there had been concerns about dosing and a potential increased risk of heart attack and stroke.

Nevertheless the regulator has now approved the 40mg and 80mg doses of febuxostat (Takeda did not pursue a bid to get the go-ahead for a 120mg version) on the basis of a Phase III trial, comparing Uloric with allopurinol, the most commonly prescribed treatment to lower levels of uric acid which was approved by the FDA in 1966. The study demonstrated that febuxostat 80 mg was superior to the 40 mg dose and allopurinol 300/200 mg (67%, 45% and 42% respectively) at achieving the primary end point of serum uric acid less than 6.0 mg/dL at the final visit.

Alan MacKenzie, chief executive of Takeda’s North America operations, said that the FDA thumbs-up is a major event for the firm, “as it marks our second approval within a month”. He was referring to the US approval given to Kapidex (dexlansoprazole), a reformulated version of its acid reflux drug Prevacid.

Teijin president Osamu Nishikawa noted that the FDA approval, coupled with the green light granted to partner Ipsen in Europe last May, “ 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”, he added.