Article preview from "The Pink Sheet" December 2, 2008
Find out why Strong efficacy data and a desperate need for new gout therapies outweigh the potential cardiovascular risk associated with Takeda's febuxostat, an FDA advisory committee determined in recommending approval of the drug during a Nov. 24 meeting.
Article preview from "The Pink Sheet" December 2, 2008
Takeda Febuxostat Benefits Outweigh CV Risk; Will Other Gout Drugs Follow?
Strong efficacy data and a desperate need for new gout therapies outweigh the potential cardiovascular risk associated with Takeda's febuxostat, an FDA advisory committee determined in recommending approval of the drug during a Nov. 24 meeting.
Yet despite the near-unanimous vote (12-0 with one abstention), members of the Arthritis Drugs Advisory Committee expressed concern over a potential cardiovascular signal and encouraged FDA to use its post-approval authorities to require further study.
Febuxostat is a non-purine selective xanthine oxidase inhibitor; Takeda is seeking an indication for the management of hyperuricemia in patients with chronic gout. The user fee goal for the standard review is Jan. 16, 2009.
Will Takeda Succeed Where Others Have Failed?
Should FDA agree with the advisory committee and approve febuxostat - which Takeda hopes to market as Uloric - it would be the first new drug approved for gout in 40 years. Other gout drugs developed in recent years have been denied approval by FDA.
For example, Cardiome's Oxyprim (oxypurinol), an active metabolite of the only other available prescription treatment for gout - the purine non-selective xanthine oxidase inhibitor allopurinol - never made it past the Arthritis advisory committee
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