The Arthritis Advisory Committee of the FDA did not recommend approval of sirukumab (proposed trade name PLIVENSIA) for the treatment of moderately to severely active rheumatoid arthritis.- Janssen Biotech

Janssen Biotech, Inc. announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) did not recommend approval of sirukumab (proposed trade name PLIVENSIA�) for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).

Sirukumab is an anti-interleukin (IL)-6 monoclonal antibody that blocks the IL-6 pathway differently than IL-6 inhibitors currently approved for the treatment of RA. Janssen Biotech, Inc. announced submission of a Biologics License Application (BLA) to the FDA seeking approval of sirukumab on September 23, 2016.