J&J(US:JNJ) ZACKS·2024-11-25 15:10Core Viewpoint - Johnson & Johnson (J&J) is seeking FDA approval for a subcutaneous (SC) induction regimen of its immunology drug Tremfya for ulcerative colitis (UC), aiming to provide a more convenient treatment option for patients [1][3]. Company Developments - Tremfya has recently been approved by the FDA for treating adults with moderately to severely active UC as both induction and maintenance therapy, with the current induction dose only available via intravenous (IV) administration [2]. - The new SC administration is expected to be more comfortable and quicker to administer compared to the IV option, making it the first IL-23 inhibitor to offer both administration routes for UC [3]. - The regulatory submission is based on positive results from the phase III ASTRO study, which met its primary endpoint of clinical remission at week 12 and achieved all secondary endpoints [4]. Financial Performance - Tremfya generated sales of $2.7 billion in the first nine months of 2024, reflecting a 22% year-over-year increase, driven by strong market growth and share gains [9]. - J&J anticipates Tremfya could become a $5 billion product with potential approvals for both UC and Crohn's disease (CD) indications [9]. Market Context - The inflammatory bowel disease (IBD) market is competitive, with key players like AbbVie and Eli Lilly also making significant strides in this space [10][11]. - J&J's existing drug Stelara is expected to lose market exclusivity in the U.S. next year, and its sales will be affected by price cuts under the U.S. government's drug price negotiation program starting in 2026, making Tremfya's label expansion crucial for maintaining revenue [8]. Industry Trends - There has been an increase in the prevalence of IBD due to genetic, environmental, and lifestyle factors, which is driving demand for effective treatments [7]. - The focus on early diagnosis and favorable reimbursement policies in developed countries further supports the growth of IBD treatment options [7].