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Humira Shows Benefit In New Arthritis Indications Based On Novel Criteria

This article was originally published in The Pink Sheet Daily

Executive Summary

Abbott’s anti-TNF demonstrated an improvement in two subsets of spondyloarthritis patients using new criteria developed by the SpondyloArthritis International Society to identify and test patients.

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FDA Panel Looks To Insurers To Enforce TNF Inhibitor Use Restrictions In Spondyloarthritis

Arthritis Advisory Committee recommends adding an axial spondyloarthritis claim to the label of UCB’s Cimzia but not Abbott’s Humira; concerns about potential misuse in back pain patients who do not have the inflammatory condition weigh heavily during the panel’s two-day meeting on the novel indication.

FDA Panel Gives Nod To Spondyloarthritis Claim For Cimzia, But Not Humira

Arthritis Advisory Committee narrowly endorses approval of UCB’s TNF inhibitor but recommends the proposed indication for active disease be more limited. The same panel overwhelmingly rejects AbbVie’s bid to expand adalimumab’s use on concerns that the patient population studied was not well defined.

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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