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AstraZeneca’s Gout Drug Comes Into Question

FDA reviewers examine safety risks of the medication

Clinical trials show the gout drug lesinurad (AstraZeneca) is effective but may cause serious side effects, according to documents released in advance of an FDA advisory committee meeting.

AstraZeneca acquired lesinurad as part of its $1.3 billion buyout of Ardea Biosciences in 2013. The medication is a selective uric acid reabsorption inhibitor that blocks the URAT1 transporter; as a result, it treats gout by normalizing acid excretion and reducing serum levels.

The FDA’s independent committee on arthritis is set to review the lesinurad application on Friday, October 23. Fierce Biotech reports that in phase III trials, AstraZeneca tested two doses of lesinurad (200 mg and 400 mg) alongside standard therapy. The larger dose led to significant reductions in serum uric acid (sUA), but not without marked increases in renal adverse events — many of them serious — and spikes in cardiovascular risks, the FDA said in briefing documents.

The 200-mg dose was better tolerated, according to reviewers, but didn't perform as well on its efficacy goals, getting 30% more patients to target sUA levels in two trials but missing statistical significance in a third. As Reuters notes, consensus forecasts by Thompson Reuters Coretellis had predicted that the medication would earn annual sales of $350 million by 2020.

The medication might not be effective enough to outweigh its safety risks, according to the FDA staff, casting doubts on the drug's future as it heads for a key panel vote. On Friday, panelists will weigh in on whether 200 mg of lesinurad merits approval anyway. The FDA is not required to follow the advice of its committees, but it commonly does.

Source: Fierce Biotech, October 21, 2015; and Reuters, October 21, 2015.

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