With another inflammatory bowel disease (IBD) approval in the bag for Tremfya, Johnson & Johnson continues to make good on the succession plan for its declining autoimmune blockbuster Stelara.

Thursday, the FDA approved Tremfya (guselkumab) as a treatment option for adults with moderately to severely active Crohn’s disease, the company said in a press release.

The green light marks Tremfya’s fourth FDA approval since the drug won an initial nod to treat plaque psoriasis in 2017. More recently, the antibody in September picked up its first IBD nod in moderate to severe ulcerative colitis.

The growing list of indications is key to J&J’s plan for Tremfya to assume the immunology mantle from the company’s aging blockbuster Stelara, which is now facing biosimilar competition in both Europe and the U.S. Stelara sales declined 4% last year, and J&J is expecting more sales erosion now that U.S. biosimilars are available.

Crohn’s is one of two manifestations of IBD alongside ulcerative colitis. Collectively, J&J estimates that the inflammatory bowel conditions affect nearly 3 million people in the U.S.

While other advanced IL-23 therapies already exist to treat Crohn’s—such as AbbVie’s Skyrizi—those medicines require infusions at brick-and-mortar clinics at the start of treatment, which can be burdensome for patients, J&J noted in its approval announcement. By comparison, in Crohn’s, Tremfya is now allowed both as an IV and self-administered subcutaneous drug from the beginning of treatment.

J&J has applied to the FDA in hopes of winning a subcutaneous approval for Tremfya in ulcerative colitis, too.

Tremfya's Crohn’s approval was based on multiple late-stage clinical trials that studied both of the drug's dosing routes against placebo in the induction and maintenance settings.

In the induction setting, subcutaneous Tremfya at 400 mg helped 34% of patients achieve endoscopic responses versus 15% of patients on placebo at 12 weeks. Meanwhile, 56% of Tremfya patients achieved clinical remission compared to just 22% of those in the control arm. The drug performed similarly well in the induction setting at an infused, 200-mg dose, J&J said in its approval announcement. 

Crohn’s disease will likely prove to be a key approval for J&J’s Tremfya growth ambitions, though the field of IBD biologics is already rife with competition. Eli Lilly’s Omvoh became the first IL-23 drug approved in ulcerative colitis in October 2023, while AbbVie’s Skyrizi hit the scene as the first IL-23 med cleared by the FDA to treat Crohn’s in mid-2022.

Much like with Tremfya and Stelara, AbbVie has pinned its hopes on Skyrizi to fill the gap left by Humira’s loss of exclusivity in 2023. So far, AbbVie’s plans have played out about as well as the company could have expected.

Meanwhile, J&J executives recently communicated that Stelara biosimilars could actually be a boon for Tremfya in the long run, suggesting the drug could have a similar trajectory to Skyrizi and Humira.

“I think there are a lot of patients in the immunology market right now that are in need of advanced therapies or are in need of better therapies than they’re on now, and so we do see, across the board, shifting of patients and movement into the newer and better products,” Jennifer Taubert, J&J’s worldwide chairman of innovative medicines, said on a January earnings call.

“I would put Tremfya squarely in that camp,” she said.