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Regeneron Likely Facing New Gout Study Following Arcalyst “Complete Response” Letter

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s decision not to approve rilonacept for preventing gout flares was unsurprising, given its Arthritis Advisory Committee’s unanimous recommendation against the indication. Regeneron says FDA’s letter requests “additional clinical data,” as well as chemistry, manufacturing and controls information.

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