Tremfya closer to second US indication

The US Food and Drug Administration (FDA) has been asked to approve Tremfya (guselkumab) in a second indication.

A supplemental Biologics License Application has been submitted for the therapy in active psoriatic arthritis (PsA), seeking to add to the first indication in moderate to severe plaque psoriasis, which was granted by the FDA in July 2017, making it the first approved selective IL-23 inhibitor.

Tremfya belongs to Janssen, the pharma arm of diversified US healthcare giant Johnson & Johnson (NYSE: JNJ), and the company sought to prove its efficacy in PsA through the Phase III DISCOVER-1 and DISCOVER-2 studies, which met their primary endpoints of patients achieving an American College of Rheumatology 20% improvement response after 24 weeks of treatment.