SPRING HOUSE, Pa. - Johnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of TREMFYA® (guselkumab) to treat adults with moderately to severely active Crohn's disease.
This submission is supported by 48-week results from the Phase 3 GALAXI and GRAVITI programs, which indicate that TREMFYA® could become the first IL-23 inhibitor to offer both subcutaneous (SC) and intravenous (IV) induction therapy options for this condition.
The GALAXI program, which includes Phase 2 and 3 studies, evaluated the efficacy and safety of guselkumab in participants with Crohn's disease who had an inadequate response to conventional therapies or biologics. The results demonstrated that TREMFYA® met the co-primary endpoints for SC maintenance doses and showed superiority to ustekinumab in endoscopic endpoints.
Similarly, the GRAVITI study assessed TREMFYA® SC induction therapy, meeting its co-primary endpoints for clinical remission and endoscopic response at Week 12, with all multiplicity-controlled endpoints being met up to Week 48 compared to placebo.
David Lee, M.D., Ph.D., Global Therapeutic Area Head Immunology at Johnson & Johnson, emphasized the company's commitment to addressing the needs of people living with Crohn's disease and expressed hope for the FDA's review of the data.
TREMFYA®, a fully-human monoclonal antibody, blocks IL-23 and binds to CD64, potentially impacting the immune-mediated processes of Crohn's disease. It was first approved in July 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis and later for active psoriatic arthritis in July 2020.
The European Medicines Agency (EMA) has also received applications from Janssen-Cilag International NV, a Johnson & Johnson company, for the expansion of TREMFYA®'s indications to include ulcerative colitis and Crohn's disease.
This news is based on a press release statement from Johnson & Johnson. The company's ongoing commitment to immunology and innovation is evident in its pursuit of expanding TREMFYA®'s indications, potentially offering new treatment options for patients with inflammatory bowel diseases.
In other recent news, Johnson & Johnson (J&J) has been subject to a unique class action lawsuit seeking medical monitoring for women who may develop cancer from the use of the company's talc-based products.
Simultaneously, the company has submitted a Biologics License Application to the FDA for a new cancer treatment, amivantamab. On the financial front, RBC Capital has maintained an Outperform rating on J&J, following the presentation of encouraging data at a recent analyst meeting.
In the realm of treatment developments, J&J presented promising long-term data from its MonumenTAL-1 study, indicating durable responses in patients treated with its multiple myeloma treatment, TALVEY®. Meanwhile, law firms involved in opioid crisis settlements, which implicated J&J among other companies, were awarded a $2.13 billion legal fee pool.
These recent developments provide an overview of the various challenges and advancements J&J is currently navigating.
InvestingPro Insights
As Johnson & Johnson (NYSE: JNJ) seeks to expand the indications of TREMFYA® into the treatment of Crohn's disease, the company's financial health remains a key consideration for investors. With a robust market capitalization of $356.16 billion and a trailing twelve months revenue of $85.65 billion as of Q1 2023, JNJ's financial stability is evident.
The company's dedication to shareholder returns is highlighted by its impressive track record of increasing its dividend for 54 consecutive years, a testament to its financial strength and commitment to investors.
Investors may also find reassurance in JNJ's low price volatility, making it a potentially attractive option for those seeking stability in their portfolios. Additionally, JNJ's dividend yield stood at 3.41% as of mid-2024, further showcasing its role as a consistent income-generating stock.
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