Mario Tama
- Johnson & Johnson (NYSE:JNJ) Innovative Medicines, formerly known as Janssen, has submitted a supplemental biologics license application to the U.S. FDA to seek approval of Tremfya (guselkumab) for ulcerative colitis.
- J&J (JNJ) is supporting its application with data from the phase 3 QUASAR trial which enrolled people with UC who had an inadequate response or intolerance to other therapies, including biologics and/or JAK inhibitors.
- Tremfya is a dual-acting IL-23 blocker. It is already approved for plaque psoriasis and psoriatic arthritis.