U.S. FDA approves TREMFYA® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease
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Johnson & Johnson (JNJ) received FDA approval for TREMFYA® (guselkumab), a novel IL-23 inhibitor for treating moderately to severely active Crohn's disease. This approval marks the fourth indication for the drug in the U.S. and offers both subcutaneous and intravenous induction options. The drug is notable for being the first fully-human, dual-acting monoclonal antibody that blocks IL-23 and binds to CD64.
March 20, 2025 | 10:30 pm
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FDA approval of TREMFYA® for Crohn's disease represents a significant expansion of JNJ's treatment options in inflammatory bowel disease, potentially increasing the drug's market potential.
FDA approval of a new indication typically signals positive market potential, expanded revenue opportunities, and strengthens the company's pharmaceutical pipeline. The unique dual-action mechanism and multiple indications make this approval particularly promising.
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