Meeting Announcement – HUMIRA

Posted by on June 10, 2013

July 23, 2013 8:00 a.m. to 5:30 p.m.: Arthritis Advisory Committee Meeting Announcement

 

Where:  FDA White Oak Campus
               Building 31
               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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