J&J powers on with Tremfya with UC SC filing

US healthcare giant Johnson & Johnson (NYSE: JNJ) has filed a supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) for a subcutaneous (SC) induction regimen of Tremfya (guselkumab) to treat moderately to severely active ulcerative colitis (UC). 

Tremfya received FDA approval in September of this year for the treatment of adult patients with moderately to severely active UC and is currently administered via an intravenous (IV) induction regimen, followed by a SC maintenance regimen. 

It is the first and only approved, dual-acting monoclonal antibody that blocks interleukin (IL)-23 while also binding to CD64, a receptor on cells that produce IL-23, a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC.