J&J's Tremfya Approved by FDA for Ulcerative Colitis

With its recent approval for treating ulcerative colitis (UC), Tremfya is poised to make a significant impact on the competitive inflammatory bowel disease (IBD) market. Johnson & Johnson (J&J), already a dominant player in this space with its well-known drug Stelara, has announced that the FDA has approved Tremfya for moderate to severely active UC. This new indication opens up a large market for Tremfya, which affects over 1.2 million Americans. Launched in 2017 for plaque psoriasis and later approved for psoriatic arthritis, Tremfya is a dual-acting IL-23 inhibitor that aims to neutralize inflammation by blocking IL-23 and binding to the CD64 receptor.

In a recent UC maintenance study, Tremfya showed promising results. At the 44-week mark, 50% of patients receiving a 200-mg dose every four weeks achieved clinical remission, while 45.2% of those on a 100-mg dose every eight weeks also met this benchmark. In contrast, only 18.9% of patients on placebo reached clinical remission. Further analysis indicated that roughly two-thirds of those in clinical remission also achieved endoscopic remission by Week 44, suggesting their intestinal lining appeared normal.

A separate phase 3 induction study demonstrated early responses to Tremfya as well. By Week 1, 28.3% of patients treated with Tremfya reported an early symptomatic response, compared to 18.9% for those on placebo. By Week 12, the response rate for Tremfya-treated patients surged to 71.7%, significantly higher than the 35% observed in the placebo group.

Tremfya's entry into the UC market follows closely behind AbbVie’s Skyrizi, which also recently received approval for UC. Like Tremfya, Skyrizi is expected to fill the shoes of AbbVie’s once-dominant Humira. Although Skyrizi has an advantage with its prior approval for Crohn’s disease—the second form of IBD—it faces strong competition. In head-to-head studies, Skyrizi outperformed Stelara in Crohn’s disease treatment. Similarly, Tremfya has shown superior results over Stelara in treating Crohn’s disease, based on recent phase 3 studies that measured endoscopic and clinical remission rates. J&J submitted an application for Tremfya's approval in this indication in June.

Financially, Tremfya generated $2.1 billion in sales last year, while Stelara brought in $6.9 billion. However, Stelara faces looming challenges. In 2025, Amgen is expected to launch biosimilar versions of Stelara, which will likely impact its market share. Additionally, Stelara has been selected for Medicare price negotiations, which means it will face a price reduction in 2026.

Overall, the approval of Tremfya for UC not only provides a new treatment option for patients but also strategically positions J&J to maintain its stronghold in the IBD market amid the impending competition and regulatory changes affecting Stelara.