J&J Seeks FDA Approval for Tremfya for Psoriasis in Kids

Core Viewpoint - Johnson & Johnson (JNJ) has filed two supplemental biologics license applications (sBLA) for its drug Tremfya, seeking expanded use in pediatric patients for moderate-to-severe plaque psoriasis and active juvenile psoriatic arthritis [1][3] Company Summary - Tremfya is an IL-23 inhibitor already approved for adult patients with plaque psoriasis and active psoriatic arthritis in multiple countries, including the United States and the EU [2] - Tremfya generated sales of $2.7 billion in the first nine months of 2024, reflecting a year-over-year increase of 21.6$5 billion product, particularly with approvals for inflammatory bowel disease (IBD) conditions [7] Product Development - The sBLA for plaque psoriasis is based on data from the phase III PROTOSTAR study in pediatric patients, while the juvenile psoriatic arthritis filing relies on pharmacokinetic extrapolation from adult studies [3] - Tremfya was approved by the FDA for moderately to severely active ulcerative colitis (UC) in September 2023 and is under review in the EU for the same condition, as well as for Crohn's disease (CD) [6] Market Dynamics - There has been an increase in gastrointestinal disorders like UC and CD, driven by genetic, environmental, and lifestyle factors, which is boosting demand for IBD treatments [8] - Major competitors in the IBD market include AbbVie, Eli Lilly, Pfizer, Novartis, Merck, Sanofi, Gilead, and Amgen, all of which are developing new therapies with novel mechanisms of action [9] Competitive Landscape - AbbVie expects its immunology drugs Skyrizi and Rinvoq to double sales in IBD indications in 2024, supported by recent acquisitions of smaller biotech firms [10] - Lilly's new drug Omvoh has been approved for UC, and it has filed for CD in multiple regions, while also acquiring Morphic Therapeutics for IBD treatment [11] - Merck and Roche have made strategic acquisitions to enhance their IBD pipelines, focusing on novel therapies [12][13]