FDA committee mixed on axial spondyloarthritis

FDA's Arthritis Advisory Committee voted to expand the label of one autoimmune drug to include axial spondyloarthritis but voted against expanding the label of a second drug to include the indication. The committee voted 7-6, with one abstention, in favor of approving an sBLA from UCB Group (Euronext:UCB) to expand the label of Cimzia certolizumab pegol to include treatment of active axial spondyloarthritis in adults, including patients with ankylosing spondylitis. However, the panel voted 12-1, with one abstention, against approving an sBLA from AbbVie Inc. (NYSE:ABBV) to expand the label of Humira adalimumab to include treatment of active non-radiographic axial spondyloarthritis in adults who have had an inadequate response to or who are intolerant to an NSAID.

Cimzia is approved in the EU and U.S. to treat rheumatoid arthritis (RA) and in the U.S. to treat Crohn's disease. Humira is approved in the EU and U.S. to treat a variety of autoimmune conditions, including Crohn's disease, RA and ankylosing spondylitis. The PDUFA dates for both are undisclosed. The AbbVie vote came during market hours, while the UCB vote was after market close. AbbVie was off $0.66 to $44.31 on Tuesday. UCB was up EUR 0.62 to EUR 42.19 on the day. ...