FDA Approves Johnson & Johnson’s Tremfya For Crohn’s Disease

On Thursday, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s (NYSE JNJ) Tremfya (guselkumab), the first and only IL-23 inhibitor offering subcutaneous (SC) and intravenous (IV) induction options, for adults with moderately to severely active Crohn’s disease (CD), a chronic inflammatory condition of the gastrointestinal tract.

This approval is supported by results from multiple Phase 3 trials evaluating more than 1,300 patients with moderately to severely active CD who failed or were intolerant to conventional therapy or biologics.

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The GRAVITI study evaluated Tremfya SC induction and maintenance therapy versus placebo. 

Data from the GALAXI clinical program showed that Tremfya was superior to the company’s Stelara in all pooled endoscopic endpoints.

This approval marks the fourth indication for Tremfya in the U.S., following moderate-to-severe plaque psoriasis in July 2017, active psoriatic arthritis in July 2020, and moderately to severely active ulcerative colitis (UC) in September 2024.

In November 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of an SC induction regimen of Tremfya for adults with moderately to severely active UC based on the results of the Phase 3 ASTRO study.

In 2024, Tremfya generated sales of $3.67 billion, up 17% year over year.

Price Action: JNJ stock is down 0.15% at $162.77 during the premarket session at the last check Friday.

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