Johnson & Johnson (NYSE: JNJ) announced today that the US Food and Drug Administration (FDA) has granted approval for Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). With this approval, Tremfya stands out as the sole fully-human, dual-acting monoclonal antibody that not only blocks IL-23 but also binds to CD64, a receptor on cells responsible for producing IL-23. IL-23, a cytokine released by activated monocyte/macrophages and dendritic cells, is recognized as a key driver in immune-mediated diseases, including UC.
This marks the fourth approval for different autoimmune disease indications in the United States for Tremfya, following its initial FDA approval in 2017 for the treatment of plaque psoriasis. The drug entered the market later than other antibody treatments for autoimmune diseases, such as Novartis’s IL-17-targeted antibody in Cosentyx (secukinumab), Eli Lilly’s Taltz (ixekizumab), and Bausch Health’s Siliq (brodalumab). – Flcube.com
