J&J's Tremfya Gains FDA Approval for IBD Indications Amid Intensifying IL-23 Market Competition

Johnson & Johnson announced on Wednesday local time that the FDA has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC)., an inflammatory bowel disease (IBD) that affects more than 1.2 million Americans. The expanded label opens up a major market for this biologic, which was first launched in 2017 for the treatment of plaque psoriasis and received a second approval for psoriatic arthritis three years later. This dual-action IL-23 inhibitor is designed to neutralize inflammation by blocking IL-23 and binding to the CD64 receptor.

Johnson & Johnson has already secured a significant position in the crowded inflammatory bowel disease field with its popular drug Stelara (ustekinumab). However, as the patent cliff for this blockbuster autoimmune product approaches, biosimilar versions are quickly nearing, with Amgen planning to launch a series of Stelara biosimilars in 2025. Additionally, pricing pressures from the Inflation Reduction Act (IRA) will soon follow, as Stelara was selected as one of ten drugs eligible for Medicare price negotiations and will face price reductions in 2026. For now, the FDA's approval of a new indication for Johnson & Johnson’s Tremfya will undoubtedly provide a welcome boost to the company.

In a recent maintenance study of ulcerative colitis (UC), 50% of patients receiving a 200 mg subcutaneous dose of Tremfya every 4 weeks and 45.2% of patients taking a 100 mg dose every 8 weeks met the criteria for clinical remission by week 44 of the study. In comparison, only 18.9% in the placebo group achieved this outcome. In another independent phase 3 induction study, responses to Tremfya were observed as early as the first week. In this study, 28.3% of patients treated with Tremfya achieved an early symptom response, compared to 18.9% in the placebo group. By week 12, the proportion in the Tremfya group increased to 71.7%, while that in the placebo group was 35%.

But the IL-23 track is becoming increasingly crowded,Just months before Tremfya's development for UC, AbbVie's follow-up drug, Skyrizi (risankizumab), also received regulatory approval for the condition.Like Tremfya, Skyrizi, as the successor to AbbVie's once-dominant Humira, also shoulders significant responsibility.

Skyrizi was approved by the FDA in June 2022, becoming the first treatment for moderate to severe active Crohn's disease (CD）Therapeutic drugs.According to phase 3 results presented at Digestive Disease Week (DDW) 2024, two different doses of Tremfya showed superior endoscopic improvement in patients with moderate to severe active Crohn's disease (CD) compared to Johnson & Johnson's Stelara in a head-to-head trial.Among patients taking Skyrizi, 61% achieved clinical remission by week 48, compared to only 41% of those taking Stelara. The endoscopic remission rate for Skyrizi also doubled, reaching 32%.

Similarly, at DDW, Eli Lilly also announced its CD data for Omvoh (Mirikizumab-mrkz),Omvoh was approved by the FDA in October 2023 as the first IL-23 drug approved for the treatment of UC.。

Of course, Johnson & Johnson remains highly confident in Tremfya. In June this year, the subcutaneous (SC) version of Tremfya demonstrated strong performance as an induction therapy in a Phase 3 study for Crohn's disease. In the GRAVITI trial, Tremfya achieved both co-primary endpoints, showing statistically significant improvements in remission and endoscopic response at week 12 compared to placebo.

Johnson & Johnson stated in a press release that the results of three studies indicate Tremfya has the potential to become the first IL-23 inhibitor to offer two induction options (SC and IV induction) for Crohn's disease. Based on the trial results, Johnson & Johnson submitted an application for Tremfya’s Crohn's disease-related indications in June.

Tremfya's sales revenue in H1 2024 was $1.714 billion, representing a year-on-year increase of 27.34%.According to Johnson & Johnson CEO Joaquin Duato's statement during the company’s Q1 earnings call in April, Tremfya has now surpassed Stelara in sales for its approved indications of plaque psoriasis and psoriatic arthritis.

However, despite this, AbbVie's Chief Commercial Officer Jeff Stewart said on the Q1 earnings call in April that Skyrizi holds over 35% of total prescription share in the U.S. biologic psoriasis market, more than double the share of the next biologic competitor.In the IBD field, Skyrizi has already taken the leading position in the U.S. Crohn's disease market and is expected to achieve more than $1 billion in growth this year.

With AbbVie full of confidence ahead and Eli Lilly eyeing opportunities behind, Johnson & Johnson also shows great promise in the immunology field. The question of which of the three companies will take the lead remains to be seen, and Yidu Pharma will continue to monitor the situation.

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