J&J's Tremfya Approved for Ulcerative Colitis, Succeeding Stelara

Johnson & Johnson has achieved a significant milestone with the FDA's approval of its therapeutic antibody Tremfya (guselkumab) for treating adult patients suffering from moderate to severe active ulcerative colitis (UC). Tremfya stands out as the first and only fully-human, dual-acting monoclonal antibody specifically for UC. It operates by blocking IL-23 to reduce inflammation and targeting the CD64 receptor on cells, including activated macrophages and monocytes, involved in the secretion of IL-23.

Christopher Gasink, J&J’s vice president for medical affairs in gastroenterology and autoantibody sectors, emphasized that this approval offers UC patients a new treatment alternative that not only alleviates symptoms but also holds the potential for remission. J&J is also pursuing regulatory approval for Tremfya in Crohn’s disease. Currently, Tremfya is already sanctioned for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis.

The FDA’s decision is supported by data from the Phase IIb/III QUASAR study, a randomized, double-blind, parallel-group trial. This study examined the efficacy of 200-mg and 100-mg doses of Tremfya in patients who had shown inadequate response or intolerance to conventional treatments, including biologics and JAK inhibitors. The results were promising: 50% of patients administered 200 mg of Tremfya every four weeks achieved clinical remission at 44 weeks, compared to just 19% in the placebo group. Similarly, those on a lower dose of 100 mg every eight weeks had a 45% remission rate. Both doses demonstrated statistically significant improvements over placebo.

Endoscopic remission rates at one year were also notably higher in the Tremfya groups, with 34% and 35% for the 200-mg and 100-mg doses respectively, compared to 15% in the placebo group. The QUASAR study further affirmed Tremfya’s well-established safety profile, thereby "raising the bar for efficacy in the treatment of this inflammatory bowel disease," according to Gasink.

This FDA approval is a strategic move for Johnson & Johnson, especially as its blockbuster drug Stelara (ustekinumab) faces increasing competition from biosimilars. Stelara, first approved in 2009 for moderate-to-severe plaque psoriasis, has since expanded to treat ulcerative colitis and Crohn’s disease among other conditions. In 2023, Stelara generated $10.9 billion in sales, marking an 11.7% increase compared to the previous year. However, the recent expiration of a key patent has opened the market to biosimilars. 

In November 2023, Amgen gained approval for Wezlana (ustekinumab-auub), an interchangeable biosimilar for several inflammatory conditions. Following this, Teva and Alvotech received regulatory approval in April 2024 for Selarsdi (ustekinumab-aekn), which is expected to launch in early 2025.

Adding to J&J’s challenges, Cigna’s Evernorth Health Services recently announced plans to offer patients an interchangeable biosimilar at no out-of-pocket cost starting next year. This move is expected to further impact Stelara's market share.

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