J&J adds to IL-23 options in Crohn's after FDA approval

Johnson & Johnson's IL-23 inhibitor Tremfya has been approved by the FDA as a treatment for Crohn's disease, becoming the first drug in the class available in both intravenous and subcutaneous formulations for the inflammatory bowel disease (IBD).

Tremfya (guselkumab) is also the only drug in the class to achieve clinical remission and endoscopic response at one year with a fully subcutaneous treatment regimen, according to the drugmaker.

The antibody is already approved to treat plaque psoriasis, psoriatic arthritis and, since last September, in ulcerative colitis, achieving sales of almost $3.7 billion last year, but J&J has said that it expects the product to accelerate further now that it is approved for both of the two main forms of IBD.

It is, however, facing an increasingly competitive market and will have to vie with a clutch of other IL-23-acting drugs, including AbbVie's Skyrizi (risankizumab) – the first drug in the class to be approved for Crohn's in 2022 – Eli Lilly's Omvoh (mirikizumab), which got the go-ahead from the FDA in January, and Sun Pharma's Ilumya (tildrakizumab).

J&J's older IL-23 drug Stelara (ustekinumab) is also approved for Crohn's and remains a big seller, making upwards of $10 billion across multiple indications. However, it has been outperformed in head-to-head trials by Tremfya, as well as Skyrizi, which approached $12 billion in sales last year and is viewed as J&J's fiercest rival in the market.

According to J&J's chair of innovative medicines, Jennifer Taubert, Tremfya has the profile needed to make headway in the IBD market.

"It's the only dual-acting IL-23 agent in IBD, acting on both IL-23 [and] CD64," she said on the company's recent fourth-quarter results call. "We think it's got the potential to really set the next bar in efficacy and we know there are a lot of patients who need more and are ready to switch," she added.

Taubert also pointed to the increased flexibility afforded by having a subcutaneous option for both induction and maintenance dosing in Crohn's, as well as an IV version.

The FDA approval of Tremfya in Crohn's is supported by the GRAVITI and GALAXI studies, of which the latter showed that Tremfya was superior to Stelara on all pooled endoscopic endpoints. J&J claims Tremfya is the only IL-23 inhibitor to achieve this in a double-blinded pivotal trial.

GlobalData is projecting strong growth for Tremfya, but still sees it playing second fiddle to Skyrizi in the coming years. It thinks Skyrizi will reach nearly $22 billion by 2030 across all its approved indications, with Tremfya expected to make $8.7 billion in the same year.