With a fresh endorsement from the FDA, Johnson & Johnson has rounded out Tremfya’s presence in inflammatory bowel disease (IBD) and, in doing so, achieved a first for the IL-23 inhibitor drug class.
Friday, the FDA approved a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis (UC).
The green light builds on Tremfya’s initial intravenous nod in UC secured last September, making the medicine the first IL-23 inhibitor to offer both under-the-skin injection and IV dosing options from the beginning of treatment through maintenance therapy for IBD patients, J&J said in a press release.
Back in March, the drug—which also goes by the generic moniker guselkumab—won IV and subcutaneous approvals to treat adults with Crohn’s disease, the second manifestation of IBD alongside UC.
Collectively, J&J has estimated that UC and Crohn’s affect nearly 3 million people in the U.S. While multiple other IL-23 therapies—such as AbbVie’s Skyrizi, Eli Lilly’s Omvoh and J&J’s own Tremfya predecessor Stelara—are also approved to tackle UC, the initial doses of those biologics must be infused, which can complicate the process for patients seeking treatment.
"Historically, IL-23 inhibitors have required IV infusions at the start of therapy, which can create barriers to starting treatment or be burdensome for some patients and clinicians," David Rubin, M.D., a director at University of Chicago Medicine who served as an investigator on J&J’s subcutaneous Tremfya study, said in a statement.
The newly approved self-administration format has demonstrated efficacy and safety on par with Tremfya’s previously approved IV induction dose, Rubin added.
The FDA based its approval on data from J&J’s late-stage Astro trial, which used a treat-through design to assess subcutaneous Tremfya in adult patients who hadn’t benefited from or had an intolerance to conventional and advanced UC colitis therapies.
Injectable Tremfya's performance enabled the study to hit a range of primary and secondary endpoints, J&J noted in its approval announcement.
Notably, Tremfya triggered an early symptomatic response in UC that diverged from placebo as early as two weeks into the trial, with those results sustained through the 24-week mark, J&J said.
Meanwhile, 26% of patients on the 400-mg dose of J&J’s injectable drug achieved clinical remission at Week 12 of the study, versus just 7% of patients on placebo. Over that same span, 36% of subcutaneous Tremfya patients demonstrated endoscopic improvement, compared to 12% of participants in the trial’s control arm.
Those data largely track with results seen in J&J’s study of intravenous Tremfya induction therapy in UC, even when accounting for subgroups of patients with severe or refractory disease, J&J said. Both dosing formats started to confer benefits to patients in a similar amount of time, the company added.
Emboldened by the IBD data generated on Tremfya, J&J on Friday also noted that it is kicking off a head-to-head trial that will pit its drug against AbbVie’s Skyrizi in Crohn’s.
For J&J, the study could present a redemption opportunity after AbbVie’s drug topped its Tremfya predecessor Stelara in a Crohn’s head-to-head in 2023.
Skyrizi—which is one of two immunology drugs alongside Rinvoq that AbbVie has positioned to succeed Humira—secured a U.S. green light in UC last June. Prior to that, the IL-23 med nabbed a Crohn’s nod in 2022. Rinvoq is also approved in both indications but is part of the JAK inhibitor class rather than being an IL-23 drug.
J&J has adopted a similar approach to AbbVie’s Skyrizi-Rinvoq strategy with Tremfya. J&J’s drug has been elevated to assume the immunology mantle from Stelara, which—like AbbVie’s Humira—is now facing biosimilar competition across multiple global markets.
Earlier this year, J&J reported that Tremfya grew sales by 31% in the second quarter to $1.2 billion. The drug has already made a “great start” on its launches in both UC and Crohn’s, Jennifer Taubert, J&J’s executive vice president of innovative medicine, said on a July earnings call.