Where: FDA White Oak Campus
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
During the morning session, the committee will discuss supplemental biologic license application (sBLA) 125057, HUMIRA (adalimumab) injection, by AbbVie Inc. for the proposed indication of reducing signs and symptoms in adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation by elevated C-reactive protein (CRP) or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to, a nonsteroidal anti-inflammatory drug.
During the afternoon session, the committee will discuss (sBLA) 125160, CIMZIA (certolizumab) injection, by UCB, Inc., for the proposed indication of treatment of adult patients with active axial spondyloarthritis, including patients with ankylosing spondylitis.
Please click HERE for the current roster of the Arthritis Advisory Committee.
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