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FDA will consider Arcalyst for gout flare-ups, reviewing possible link to cancer

Filed May 8th, 2012 Laurie

The Food and Drug Administration will soon determine whether the gout drug Arcalyst should be prescribed to treat “flare ups” associated with the disease.

An agency panel will review documents collected over time on the initial studies of the drug for this new indication. The makers of the drug, Regeneron Pharmaceuticals wants Arcalyst approved to treat a 16-week window for a gout sufferer in which they are most prone to attacks common with the joint disease. Arcalyst works by lowering a gout sufferer’s uric acid content.

The FDA must consider whether the risks associated with taking Arcalyst for gout “flare ups” outweigh any potential benefit a person may gain from taking more of the drug. The agency believes there are few benefits to taking Arcalyst and that six patients participating in trials of the drug for this indication developed malignant tumors, a report from FierceBioTech.com indicates, citing an additional Bloomberg report.

Arcalyst’s seeming link to a heightened risk of cancer could be due to its ability to cause immune suppression in patients participating in a trial conducted by Regeneron to get it approved for a new indication. This approval likely would result in a considerable boost in sales of the drug, which totaled $20 million last year.

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