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Humira, Cimzia Arthritis Indications May Rest On Adequacy Of Classification Criteria

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Arthritis Advisory Committee will consider whether axial spondyloarthritis can serve as the basis for a new indication for AbbVie and UCB’s TNF inhibitors. Agency’s briefing documents raise concerns that classification criteria used in pivotal studies capture a patient population that is too broad and heterogeneous.

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