JNJ's Tremfya Gets EU Approval for Pediatric Plaque Psoriasis

Core Insights - Johnson & Johnson (JNJ) has received approval from the European Commission (EC) for the expanded use of its psoriasis drug, Tremfya, in pediatric patients aged 6 to 17 years with moderate-to-severe plaque psoriasis [1][2] - Tremfya is the first IL-23 inhibitor authorized for pediatric use in the European Union, having previously been approved for adults in 2017 [1][5] - The approval is based on data from the phase III PROTOSTAR study, which demonstrated significant efficacy in pediatric patients [2][9] Company Performance - JNJ's shares have increased by 42.1% over the past year, outperforming the industry average rise of 16.1% [4] - Tremfya generated $3.6 billion in sales during the first nine months of 2025, reflecting a 31% year-over-year growth [8][11] Study Results - The PROTOSTAR study met primary endpoints, with approximately 75% of patients treated with Tremfya achieving a PASI 75 score compared to 20% in the placebo group [9] - Additionally, 66% of Tremfya-treated patients achieved an IGA score of 0/1, compared to 16% in the placebo group [9] Drug Indications - Tremfya is approved for multiple indications, including adult plaque psoriasis, active psoriatic arthritis, and inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's Disease [10]