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Arthritis Patient Classification To Be Key Issue In TNF Inhibitor Reviews

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Arthritis Advisory Committee will meet July 22 to give its views on how identification criteria for axial spondyloarthritis impacts approval of drugs for the disease; sBLAs seeking the indication for AbbVie’s Humira and UCB’s Cimzia are pending at the agency.

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

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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