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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