HORSHAM, Pa. - Johnson & Johnson (NYSE:JNJ) announced today that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application to include evidence in the Tremfya (guselkumab) label for the inhibition of progression of structural joint damage in adults with active psoriatic arthritis.
The label update is supported by 24-week results from the Phase 3b APEX study, according to a press release statement. The study met its primary endpoint of reducing joint symptoms and its major secondary endpoint of inhibiting progression of structural damage, as measured by change in the psoriatic arthritis-modified van der Heijde-Sharp score, compared to placebo in biologic-naïve patients.The approval comes as J&J, with a market capitalization of $558 billion, continues to strengthen its pharmaceutical portfolio. According to InvestingPro analysis, the stock appears undervalued relative to its Fair Value and has delivered a 55% return over the past year. The company maintains its position as a prominent player in the pharmaceuticals industry with over $96 billion in revenue. Investors can access comprehensive analysis through InvestingPro’s detailed Pro Research Report, which provides actionable intelligence on J&J and 1,400+ other US equities.
For patients in the study’s placebo group who switched to Tremfya at Week 24, the rate of radiographic progression was reduced by 57% from Week 24 through Week 48. Data from the APEX study were consistent with the established safety profile of Tremfya, with no new safety signals identified.
Tremfya is a monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine known to be a driver of immune-mediated diseases including active psoriatic arthritis, moderate to severe plaque psoriasis, moderate to severely active ulcerative colitis and moderately to severely active Crohn’s disease.
The drug is approved in the U.S. to treat adults and children 6 years of age and older weighing at least 88 pounds with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and moderately to severely active Crohn’s disease.
The legal manufacturer for Tremfya is Janssen Biotech, Inc. Johnson & Johnson maintains exclusive worldwide marketing rights to the drug.
In other recent news, Johnson & Johnson has announced the global launch of its Shockwave C2 Aero Coronary IVL Catheter, aimed at treating calcified coronary artery disease. This next-generation catheter offers improved deliverability and enhanced lesion crossing capabilities compared to its predecessor. Additionally, Johnson & Johnson presented 18 abstracts from its neuropsychiatry portfolio at major psychiatric meetings, showcasing data on treatments for disorders such as major depressive disorder and schizophrenia.
In a significant development, DePuy Synthes, a subsidiary of Johnson & Johnson, secured an exclusive distribution agreement with CGBIO for the NOVOSIS bone graft substitute in the United States, Canada, and Australia. Meanwhile, Johnson & Johnson reported promising results from Phase 2b studies of JNJ-4804, a therapy for ulcerative colitis and Crohn’s disease, achieving higher clinical remission and endoscopic response rates compared to existing treatments.
In another update, CVS Health announced plans to prioritize biosimilars over Johnson & Johnson’s psoriasis drug Stelara in its drug lists starting in July. These recent developments reflect Johnson & Johnson’s ongoing efforts to innovate and expand its medical and pharmaceutical offerings.
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