J&J says FDA approves SC induction regimen of Tremfya

Johnson & Johnson announced that the U.S. Food and Drug Administration has approved a subcutaneous induction regimen of TREMFYA for the treatment of adults with moderately to severely active ulcerative colitis. With this approval, TREMFYA is the first and only IL-23 inhibitor to offer both SC and intravenous induction options for the treatment of UC and Crohn’s disease, which combined affect approximately three million Americans. TREMFYA is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. Findings are based on in vitro studies.