FDA Staff Question Side Effects of Regeneron Pharmaceuticals, Inc. Gout Drug

Published: May 04, 2012

Regeneron Pharmaceuticals Inc. (REGN)’s Arcalyst may not offer enough of a benefit in preventing gout flares to be worth the risk of developing cancer, U.S. regulators said. Arcalyst lowered the number of gout flares in final-phase studies, yet the benefit was “small,” Food and Drug Administration staff wrote in a report released today. The drug also is associated with a small increased risk of malignancy, the staff wrote. The agency is scheduled to convene advisers on May 8 to weigh expanding approval of the medicine.

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