FDA Advisory Committee recommends lesinurad for the treatment of hyperuricaemia associated with gout- AstraZeneca
AstraZeneca announced that the FDA Arthritis Advisory Committee (AAC) voted 10 to 4 to recommend the approval of lesinurad 200 mg tablets for the treatment of hyperuricaemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI).
The AAC reviewed safety and efficacy data from the pivotal Phase III combination therapy programme trials, representing the largest clinical trial data set of gout patients treated with combination urate lowering therapy. The Prescription Drug User Fee Act (PDUFA) target goal date for lesinurad is 29 December 2015. If approved, lesinurad will be the first selective uric acid reabsorption inhibitor, or SURI, in the US. It inhibits the urate transporter, URAT1, which is responsible for the majority of the renal reabsorption of uric acid.
Comment: Current treatments are limited to the 50-year-old generic allopurinol and Takeda and Ipsen's febuxostat, a drug approved in 2009 that does not work in every patient.
Comment: AstraZeneca filed lesinurad in the EU in January 2015.
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