U.S. drug advisers unanimously voted against Regeneron Pharmaceuticals Inc's experimental drug to prevent gout flares, based on studies that tested the drug for only 16 weeks.
A panel of outside experts to the U.S. Food and Drug Administration on Tuesday voted 11-0 against approving the injectable drug, called Arcalyst, because its clinical trials were too short to prove the treatment was safe, or that it would help patients over time.
Gout is a painful condition that occurs when the bodily waste product, uric acid, is deposited in the joints and soft tissues, causing inflammation and sometimes making it difficult to walk. It affects about 5 million to 6 million Americans.
Read more at Reuters