The label expansion could help J&J establish Tremfya as a successor to Stelara, which is now facing a growing biosimilar challenge.
The FDA signed off on the use of Johnson & Johnson’s Tremfya Thursday to treat adults with moderately to severely active Crohn’s disease. As per the pharma’s news release, Tremfya is the “first and only” IL-23 blocker that can be used intravenously and subcutaneously for this indication.
The label expansion should help J&J to better position Tremfya as a successor to its blockbuster drug Stelara. Earlier this year, the first four Stelara biosimilars hit the U.S. market, led by Amgen’s Wezlana in January. Teva and Alvotech’s Selarsdi, Sandoz’s Pyzchiva and Biocon Biologics’ Yesintek followed suit in the subsequent weeks.
Adding to J&J’s challenges in trying to market Stelara is a September 2024 announcement from Cigna Evernorth Health Services, one of the biggest insurance providers in the U.S., that it would offer a Stelara copycat this year at $0 out-of-pocket cost.
First approved in 2017 for moderate to severe plaque psoriasis, Tremfya is a human IgG1 monoclonal antibody that targets the IL-23 cytokine, blocking its interaction with its corresponding receptor. Through this mechanism of action, Tremfya suppresses the release of proinflammatory factors, in turn dampening inflammation that underlies several immune-mediated diseases. The biologic has also been approved for psoriatic arthritis and, most recently, ulcerative colitis.
Thursday’s label expansion for Tremfya is backed by data from several Phase III trials evaluating the biologic in more than 1,300 patients with Crohn’s disease who had failed or were otherwise intolerant to corticosteroids, immunomodulators or other biologics.
In its GRAVITI study, subcutaneous Tremfya led to significantly better clinical remission and endoscopic response than placebo. Tremfya beat out Stelara in terms of all pooled endoscopic endpoints in GALAXI, making it the only IL-23 blocker to best the blockbuster in a double-blinded pivotal program, according to Thursday’s release.
Chris Gasink, J&J’s vice president for Medical Affairs, Gastroenterolgy & Autoantibody said Thursday’s approval not only provides patients with a new effective treatment option but also gives them “the flexibility of self-administration from the start.” The pharma is also seeking approval for a subcutaneous formulation of Tremfya for ulcerative colitis.
Elsewhere in its immunology business, J&J earlier this month released Phase III findings for investigational oral IL-23 receptor blocker icotrokinra, touting its superiority over Bristol Myers Squibb’s Sotyktu in plaque psoriasis. J&J believes that icotrokinra could become the “new standard of treatment” in this indication.
