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

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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