J&J advances Stelara succession scheme with FDA nod for Tremfya in Crohn’s disease
New FDA Approval for Tremfya in Crohn's Disease
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The FDA has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active Crohn's disease (CD).
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Tremfya is now the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options for CD.
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This is Tremfya's fourth FDA-approved indication, following plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
Key Clinical Data
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Approval was based on multiple Phase 3 trials involving over 1,300 CD patients.
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In the GRAVITI study, subcutaneous Tremfya showed significantly better clinical remission and endoscopic response than placebo.
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The GALAXI trials demonstrated Tremfya's superiority over Stelara (ustekinumab) on all pooled endoscopic endpoints.
Positioning as Stelara Successor
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This approval advances J&J's efforts to position Tremfya as a successor to Stelara, which faces biosimilar competition.
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Stelara was J&J's top-selling drug in 2023 with $10.9 billion in sales.
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Tremfya is expected to help offset revenue loss as Stelara biosimilars enter the market in 2025.
Implications
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Expands treatment options for Crohn's disease patients.
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Strengthens J&J's immunology portfolio as Stelara sales decline.
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Positions Tremfya to compete with other IL-23 inhibitors like AbbVie's Skyrizi in the inflammatory bowel disease market.