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HORSHAM, Pa. - The U.S. Food and Drug Administration has approved Johnson & Johnson’s (NYSE:JNJ) Tremfya (guselkumab) for treating children six years and older who weigh at least 40 kg with moderate to severe plaque psoriasis and active psoriatic arthritis, the company announced Monday.
The approval makes Tremfya the first and only IL-23 inhibitor approved for these pediatric indications, building on its previous FDA approvals for adults with plaque psoriasis in 2017 and active psoriatic arthritis in 2020. This expansion aligns with J&J’s strong market performance, generating $90.6 billion in revenue over the last twelve months. InvestingPro analysis indicates the company maintains a healthy financial position with moderate debt levels and strong cash flows.
The pediatric plaque psoriasis approval was based on results from the Phase 3 PROTOSTAR study, which showed that 56% of pediatric patients receiving Tremfya achieved PASI 90 (a 90% improvement in psoriasis severity) compared to 16% on placebo at Week 16. Additionally, 66% of Tremfya patients achieved an Investigator’s Global Assessment score of 0/1 (clear/almost clear skin) versus 16% on placebo.
For pediatric psoriatic arthritis, the approval was supported by pharmacokinetic extrapolation analyses from multiple Tremfya studies in adults and children.
Approximately 20,000 children under 10 are diagnosed with plaque psoriasis annually, while about 14,000 children are affected by psoriatic arthritis. One-third of psoriasis cases begin in childhood, with the inflamed, scaly plaques potentially causing physical discomfort and emotional stress.
"The physical and emotional impact of psoriasis and psoriatic arthritis can have children sitting on the sidelines of life," said Leah M. Howard, President and CEO of the National Psoriasis Foundation, in the press release.
For pediatric patients, Tremfya is administered as a subcutaneous injection at Week 0, Week 4, and then every 8 weeks thereafter, using a 100 mg dose in a 1 mL prefilled syringe.
Common adverse events reported in the PROTOSTAR study included nasopharyngitis, upper respiratory tract infection and COVID-19. For investors seeking deeper insights into J&J’s financial health and growth prospects, InvestingPro offers comprehensive analysis through its Pro Research Report, available for over 1,400 US stocks, including detailed metrics, Fair Value assessments, and expert analysis of market positioning.
In other recent news, Johnson & Johnson has announced several key developments. The company plans to withdraw its LINX Reflux Management System from international markets starting in March, citing commercial reasons rather than safety or efficacy concerns. In the pharmaceutical sector, Johnson & Johnson reported promising results for its investigational therapy for multiple myeloma, with 100% of evaluable patients achieving minimal residual disease negativity in a Phase 2 study. Additionally, the company announced that its experimental psoriasis drug, icotrokinra, outperformed another treatment in Phase 3 trials, showing superior skin clearance.
Analyst firms have also shown confidence in Johnson & Johnson’s prospects. Guggenheim upgraded the company’s stock rating to Buy, citing strength in its pipeline and the potential for growth from its Innovative Medicine business. Goldman Sachs raised its price target for the company, highlighting the potential of new pharmaceutical product cycles, including the recently FDA-approved drug Inlexzo for bladder cancer. These developments reflect a period of active progress and strategic adjustments for Johnson & Johnson.
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