A panel of advisers to the U.S. Food and Drug Administration narrowly recommended approving Belgian drugmaker UCB SA's rheumatoid arthritis drug for an additional indication.
FDA advisers voted 7-6, with one abstention, in favor of approving the drug, certolizumab. Eight members of the 14-member panel also said the drug provides a clinically meaningful beneficial effect. One member abstained from voting.
The panel unanimously voted in support of the safety profile of the therapy.
UCB is seeking approval to market the drug for forms of inflammatory arthritis that mainly affect the spine and pelvic joints. These include active axial spondyloarthritis (SpA), ankylosing spondylitis and non-radiographic axial spondyloarthritis (nr-axSpA).
(Reporting by Pallavi Ail in Bangalore,)