New FDA approval for J&J’s IL-23 blocker Tremfya

The US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic disease of the large intestine in which the lining of the colon becomes inflamed, US healthcare giant Johnson & Johnson (NYSE: JNJ) has revealed.

J&J noted that Tremfya is the first and only approved fully-human, dual-acting monoclonal antibody that blocks interleukin (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.

J&J has been betting on Tremfya, as its other blockbuster drug for psoriasis and ulcerative colitis, Stelara (ustekinumab, is looking at a patent cliff which occurs when a company loses its patent protection, allowing cheaper biosimilars to enter the market.