Tremfya’s ulcerative colitis approval on Wednesday comes as Johnson & Johnson’s blockbuster immunotherapy Stelara continues to face growing competition from biosimilars.
The FDA on Wednesday approved Johnson & Johnson’s therapeutic antibody Tremfya (guselkumab) for the treatment of adult patients with moderate to severe active ulcerative colitis.
According to the pharma, Tremfya is now the first and only fully-human, dual-acting monoclonal antibody for ulcerative colitis (UC). Tremfya not only blocks IL-23 to dampen the inflammatory response but also targets the CD64 receptor on cells that secrete IL-23, such as activated macrophages and monocytes.
Christopher Gasink, J&J’s vice president for medical affairs, gastroenterology and autoantibody, in a statement said that the approval gives UC patients a new treatment option that provides “meaningful improvements in symptoms” as well as the “promise of remission.” J&J is also seeking approval for Tremfya in Crohn’s disease.
Tremfya is already approved for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis.
Backing Wednesday’s approval are findings from the Phase IIb/III QUASAR study, a randomized, double-blinded and parallel-group study that tested 200-mg and 100-mg doses of Tremfya in patients who had previously shown suboptimal response—or were otherwise intolerant to—conventional therapies, including biologics and JAK inhibitors.
Results showed that 50% of patients given 200 mg of Tremfya every four weeks achieved clinical remission at 44 weeks, compared with only 19% on placebo. Those who received the lower 100-mg dose every eight weeks had a clinical remission rate of 45%. The treatment effects for both dose groups were statistically superior to placebo, according to J&J.
Endoscopic remission at one year was likewise significantly better for the 200-mg and 100-mg Tremfya doses, with respective rates of 34% and 35%, versus 15% in the placebo arm. QUASAR also “reinforced the well-established safety profile” of Tremfya, the company said.
The findings continue “to raise the bar for efficacy in the treatment of this inflammatory bowel disease,” according to Gasink.
Wednesday’s approval adds to J&J’s efforts to protect its bottom line from growing biosimilar competition for its blockbuster immunotherapy Stelara (ustekinumab). First approved in 2009 for moderate-to-severe plaque psoriasis, Stelara quickly became one of J&J’s top-performing assets, winning additional indications in ulcerative colitis and Crohn’s disease, among others.
In 2023, Stelara sales jumped 11.7% year-over-year to $10.9 billion. However, the recent expiration of one of its key patent protections has opened the door to biosimilar competitors to enter the market. In November 2023, Amgen won approval for its interchangeable Stelara copycat Wezlana (ustekinumab-auub) for several inflammatory conditions. Teva and Alvotech followed suit in April 2024 with a regulatory victory for Selarsdi (ustekinumab-aekn), set to launch in early 2025.
Compounding J&J’s Stelara challenges is a recent announcement from Cigna’s Evernorth Health Services that it would offer patients an interchangeable biosimilar at $0 out-of-pocket cost starting next year.
