J&J's Tremfya Gains FDA Approval for Crohn's Disease, Advancing Stelara Succession Plan

Johnson & Johnson (J&J) has taken a significant step forward in its strategy to replace the declining blockbuster Stelara with its newer immunology drug, Tremfya. The U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active Crohn's disease, marking a crucial advancement in the drug's expanding portfolio of indications.

Tremfya's Milestone Approval

The FDA's decision makes Tremfya the first interleukin-23 (IL-23) inhibitor approved for both subcutaneous and intravenous administration in Crohn's disease treatment in the United States. This approval is Tremfya's fourth since its initial authorization for plaque psoriasis in 2017, following a recent nod for moderate-to-severe ulcerative colitis in September.

J&J's latest success with Tremfya is pivotal to its succession plan for Stelara, which faces biosimilar competition in both Europe and the U.S. Stelara sales declined 4% last year, with J&J anticipating further erosion due to the availability of U.S. biosimilars.

Clinical Trial Success and Market Positioning

The approval was based on compelling results from multiple late-stage clinical trials. In the induction setting, subcutaneous Tremfya at 400 mg demonstrated significant efficacy, with 34% of patients achieving endoscopic responses compared to 15% on placebo at 12 weeks. Moreover, 56% of Tremfya patients achieved clinical remission, surpassing the 22% in the control arm.

Tremfya's unique positioning as both an IV and self-administered subcutaneous drug from the onset of treatment sets it apart in the competitive landscape of inflammatory bowel disease (IBD) biologics. This flexibility could prove advantageous over other advanced IL-23 therapies like AbbVie's Skyrizi, which require initial infusions at clinics.

Competitive Landscape and Future Outlook

The IBD market is increasingly crowded, with recent entrants like Eli Lilly's Omvoh, approved for ulcerative colitis in October 2023, and AbbVie's Skyrizi, cleared for Crohn's disease in mid-2022. However, J&J executives remain optimistic about Tremfya's prospects, drawing parallels to Skyrizi's success in filling the gap left by Humira's loss of exclusivity.

Jennifer Taubert, J&J's worldwide chairman of innovative medicines, expressed confidence in Tremfya's potential, stating, "I think there are a lot of patients in the immunology market right now that are in need of advanced therapies or are in need of better therapies than they're on now, and so we do see, across the board, shifting of patients and movement into the newer and better products."

As J&J continues to expand Tremfya's indications, including a pending FDA application for subcutaneous approval in ulcerative colitis, the company is positioning the drug to play a central role in its immunology portfolio, potentially mirroring the successful transition seen with AbbVie's Skyrizi following Humira's patent expiration.