SPRING HOUSE, Pa. - Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for a new subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for adults with moderately to severely active ulcerative colitis (UC). This comes after the FDA approved TREMFYA® for the same condition in September 2024, which was administered via an intravenous (IV) induction regimen followed by a SC maintenance regimen.
The sBLA is based on results from the Phase 3 ASTRO study, which met its primary endpoint of clinical remission at week 12 using a 400 mg SC induction dose of TREMFYA®. The study also met all secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI). Safety results from the ASTRO study were consistent with those from the QUASAR program, which previously supported the IV induction regimen approval.
TREMFYA® is the first IL-23 inhibitor that could potentially offer a fully SC induction and maintenance regimen for UC, which, if approved, would provide a new administration option for patients and healthcare providers. Dr. Esi Lamousé-Smith, Vice President at Johnson & Johnson, highlighted the significance of the ASTRO study along with the GRAVITI study in Crohn's disease, emphasizing the company's commitment to delivering versatile treatment options for inflammatory bowel disease (IBD).
The monoclonal antibody TREMFYA® works by blocking IL-23, a cytokine known to drive immune-mediated diseases such as UC. It is also the only approved dual-acting monoclonal antibody that binds to CD64, a receptor on cells that produce IL-23.
Applications for TREMFYA® in Crohn's disease are currently under review in the U.S., and submissions for both UC and Crohn's disease have been made in Europe.
The information in this article is based on a press release statement from Johnson & Johnson.
In other recent news, Johnson & Johnson has been making significant strides in the medical field. The U.S. Food and Drug Administration (FDA) has awarded a second Breakthrough Therapy designation to nipocalimab for the treatment of Sjögren's disease. This promising development is based on Phase 2 DAHLIAS study results, revealing a greater than 70 percent relative improvement in systemic disease activity for patients receiving nipocalimab versus those on a placebo.
In addition, Johnson & Johnson has submitted applications to the FDA and European Medicines Agency for a new indication of DARZALEX FASPRO® in the treatment of high-risk smoldering multiple myeloma. If approved, DARZALEX FASPRO® would be the first sanctioned therapy for use in this patient population before the onset of full-blown disease.
Furthermore, results from the Phase 3 GRAVITI study indicate that TREMFYA® could be an effective treatment for Crohn's disease. Patients treated with TREMFYA® achieved clinical and endoscopic remission more frequently than those receiving a placebo.
In terms of financial performance, Johnson & Johnson reported robust Q3 results with operational sales growth of 6.3%, reaching $22.5 billion. Following these strong results, RBC Capital Markets and Stifel Financial (NYSE:SF) have raised their price targets for Johnson & Johnson.
However, the company also faces legal challenges, including a recent order to pay $15 million in a talc cancer case. These developments are part of recent news surrounding Johnson & Johnson, demonstrating the company's diverse operational activities and potential growth areas.
InvestingPro Insights
Johnson & Johnson's recent submission for a new subcutaneous induction regimen of TREMFYA® aligns well with the company's strong market position and financial health. According to InvestingPro data, J&J boasts a substantial market capitalization of $374.39 billion, underlining its position as a major player in the pharmaceutical industry.
An InvestingPro Tip highlights that J&J "has raised its dividend for 54 consecutive years," demonstrating a long-standing commitment to shareholder returns. This is particularly relevant in the context of the company's ongoing investment in innovative treatments like TREMFYA®. The current dividend yield stands at 3.19%, which may be attractive to income-focused investors.
Another InvestingPro Tip notes that J&J "operates with a moderate level of debt," suggesting financial stability that allows for continued research and development investments. This is crucial for maintaining its competitive edge in developing new drug administration methods, such as the subcutaneous induction regimen for TREMFYA®.
The company's revenue growth of 4.77% over the last twelve months and a strong gross profit margin of 69.39% indicate J&J's ability to fund ongoing research and potentially capitalize on new treatment options like the one described in the article.
For investors interested in a deeper analysis, InvestingPro offers 7 additional tips that could provide further insights into Johnson & Johnson's financial health and market position.
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