Arthritis Patient Classification To Be Key Issue In TNF Inhibitor Reviews

30 May 2013

• By Cathy Dombrowski

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.

With two applications for tumor necrosis factor blockers to treat adults with active axial spondyloarthritis (axSpA) on tap, the agency has scheduled a July 22 meeting to gain input from the Arthritis Advisory Committee on the implications of using classification criteria developed by the SpondyloArthritis international Society (ASAS) for identifying patients with the condition.

Issued in a 2009 ASAS handbook, the criteria allow use of Magnetic Resonance Imaging to identify adults who have axSpA....