IHS Global Insight Perspective | |
Significance | The U.S. FDA has approved Takeda's gout treatment Uloric, which the company licensed from compatriot firm Teijin for exclusive development and marketing rights in North America, in the United States. |
Implications | Although originally applying for the approval for Uloric 80-mg and 120-mg formulations, the final approval was only given to 40-mg and 80-mg dosages as a result of the FDA's suggestion for a new clinical trial with smaller dosages to clear the drugs' heart risk concerns. |
Outlook | As the first new gout drug coming into the market in over 40 years, Uloric will be in a good position to compete for the estimated 5.1 million U.S. gout patients. The approval, together with that of Kapidex delayed-release capsules granted earlier this month, will undoubtedly give Takeda a good kick-start in the U.S. market for 2009. |
The U.S. FDA has finally given its marketing approval for Japanese giant Takeda's Uloric (febuxostat), for chronic management for hyperuricaemia in patients with gout in the United States. Discovered by Teijin (Japan) and licensed exclusively to Takeda for the development and marketing rights in the United States, Uloric has demonstrated its safety and efficacy of lowering the uric acid level in hyperuricaemic patients' blood in its clinical studies. It is also the first novel inhibitor of xanthine oxidase, the uric acid producer, approved for over 40 years to treat patients suffering hyperuricaemia with gout since the launch of U.K. drug giant GlaxoSmithKline's (GSK) Zyloric (allopurinol).
Approval for Smaller Dosages After Four Years' Waiting
In December 2004, Uloric's new drug application was submitted in the United States by TAP, Takeda's U.S. joint venture with Abbott (U.S.) at that time, for 80-mg and 120-mg formulations (see United States: 16 December 2004: TAP Files NDA for Gout Drug). However, the well-hailed milestone hasn't turned out to be as smooth as expected. The FDA turned down the application twice in 2005 and 2006 due to concerns over its link to cardiovascular risks and suggested a new clinical study with lower dosage. The heart risk concerns were cleared at long last in November 2008 (see United States - Japan: 24 November 2008: FDA Clears Takeda Gout Treatment Uloric's Link to Cardiovascular Risk). Uloric's road to a desired FDA approval was then set back once again last month when Takeda was notified that the agency couldn't complete the approval review by the Prescription Drug User Fee Act (PDUFA)'s date of 18 January 2009 (see United States - Japan: 19 January 2009: FDA Delays Review Decision of Takeda's Uloric).
The final approval for Uloric was granted to 40-mg and 80-mg dosages, instead of the original 80-mg and 120-mg dosages, as the result of this long review process.
Outlook and Implications
Despite the long process of getting the final thumbs-up from the FDA, the approval of Uloric is still a significant milestone in the history of gout and hyperuricaemia as it is set to be the first new gout treatment hitting the market in over 40 years. Uloric is therefore in a good position in the competition of the U.S. gout market, which is estimated to have some 5.1 million patients.
Looking at the bigger picture of Takeda, the approval of Uloric has come as a further boost to the company's product portfolio following the recent green light secured by the company's Kapidex (dexlansoprazole) delayed-release capsules for the treatment of gastroesophageal reflux disease (GERD; see United States - Japan: 2 February 2009: Takeda's Kapidex Delayed-Release Capsules Secure FDA Approval for GERD Treatment).