FDA nod for Tremfya as J&J builds on Stelara transition
US pharma major Johnson & Johnson (NYSE: JNJ) has won US approval for Tremfya (guselkumab) in the treatment of adults with moderately to severely active Crohn’s disease, further expanding the immunology drug’s footprint and reinforcing the company’s efforts to replace revenue from declining Stelara (ustekinumab) sales.
The latest approval makes Tremfya the first interleukin (IL)-23 inhibitor cleared by the US regulator to offer both intravenous and self-administered subcutaneous induction dosing options in Crohn’s disease.
It follows a September 2024 green light for ulcerative colitis, adding to previously approved indications in plaque psoriasis and psoriatic arthritis.
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