Johnson & Johnson's antibody therapy receives FDA approval again.

Recently, Johnson & Johnson (JNJ.US) announced that the US FDA has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. According to the press release, Tremfya is the first dual mechanism IL-23 inhibitor approved for the treatment of active ulcerative colitis. In the pivotal QUASAR trial, the drug showed a significantly high endoscopic improvement rate. Tremfya is a fully human monoclonal antibody. In addition to targeting IL-23, the antibody can also bind to the receptor CD64 on cells producing IL-23. IL-23 is a cytokine secreted by activated monocytes/macrophages and dendritic cells, and is a driver of immune-mediated diseases such as UC.