Johnson & Johnson Submits sBLA for TREMFYA® as First Subcutaneous IL-23 Inhibitor Offering Comparable Efficacy to IV Induction in Moderate-to-Severe Crohn’s Disease

Jun 24, 2024 09:00 CST Updated 09:00

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

Recently, Johnson & Johnson announced that it has submitted a new application for its IL-23-targeted antibody Tremfya (guselkumab) to expand its indications for the treatment of adult patients with moderate to severe active Crohn's disease (CD). According to the official press release, Tremfya is expected to become the first IL-23 inhibitor to achieve strong endoscopic remission comparable to intravenous injection through a subcutaneous injection route, offering patients a new treatment option.

▍Johnson & Johnson&Tremfya Bring New Subcutaneous Injection Option

This supplemental Biologics License Application (sBLA) is based on data from the GALAXI Phase 3 clinical research program. Notably, GALAXI 2 and GALAXI 3 studies are the first double-blind, head-to-head registration clinical trials conducted, directly comparing the efficacy of Tremfya with the current standard treatment IL-12/IL-23 inhibitor in Crohn's disease, demonstrating superiority.

The study results showed that Tremfya, at all subcutaneous maintenance doses (200 mg every 4 weeks and 100 mg every 8 weeks) in both trials, successfully achieved the co-primary efficacy endpoints compared to placebo. Aggregating data from the two studies further revealed that Tremfya demonstrated superior performance across multiple endoscopic evaluation metrics compared to active comparator drugs, underscoring its significant potential as a preferred SC and IV induction treatment option in the field of CD treatment.

The submitted materials include the results of the Phase 3 GRAVITI study, which evaluated the efficacy of Tremfya subcutaneous induction therapy in adult patients with moderate to severe active Crohn's disease. The study results showed that the primary efficacy endpoint was met at week 12, achieving not only clinical remission but also demonstrating statistically significant and clinically meaningful improvements in endoscopic assessments. Furthermore, compared with the placebo group, Tremfya showed advantages at key evaluation points at weeks 12, 24, and 48, further confirming its therapeutic benefits.

Tremfya is a monoclonal antibody specifically targeting the p19 subunit of IL-23, effectively blocking IL-23 function. Since its approval by the U.S. FDA in 2017 for the treatment of adult patients with moderate to severe plaque psoriasis, the drug has been subsequently approved in the Chinese market in 2019, serving the same patient population suitable for systemic therapy. In 2020, its application was expanded to include psoriatic arthritis patients in the United States. Recently, Johnson & Johnson submitted an application to the European Medicines Agency (EMA) to broaden the use of Tremfya, proposing its application for treating adult patients with moderately to severely active ulcerative colitis and moderately to severe Crohn's disease.

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