New Indication Alert: J&J’s Tremfya® (Guselkumab) FDA-Approved for UC

Following a March 2024 sBLA submission, and the successful results of a phase 3 study reported in May 2024, the FDA has approved Johnson & Johnson’s Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

Tremfya® is already approved in the US for adults with moderate-to-severe plaque psoriasis and with active psoriatic arthritis.  A further sBLA for Crohn’s Disease was submitted to the FDA in June 2024.