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

 
• By Sue Sutter

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.

FDA will ask its Arthritis Advisory Committee at a July 22-23 meeting whether axial spondyloarthritis is a sufficiently well understood and defined population to support new indications for two TNF inhibitors.

The panel will be asked to consider whether recently developed criteria for classifying patients with axial spondyloarthritis (axial SpA), a...

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