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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.

Arthritis Development Strategy: Cimzia’s BLA Has More Wiggle Room, But Humira Uses Tougher Endpoint

Heading into a July 23 Arthritis Advisory Committee, AbbVie’s Humira brings a robust efficacy showing but also total reliance on a new patient diagnostic mechanism; the product’s supplemental application will be reviewed alongside a similar one for UCB’s Cimzia.

FDA’s Parks Expands REMS Portfolio With Move To ODE II Deputy Slot

Currently the head of the Division of Metabolic and Endocrinology Products, Parks has handled drug safety controversies in diabetes and obesity products.

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