Johnson & Johnson already has a major presence in the crowded inflammatory bowel disease (IBD) space with its popular Stelara. But with biosimilar versions of the autoimmune blockbuster quickly approaching and the Inflation Reduction Act's price concessions following close behind, a new FDA indication for J&J's Tremfya could provide a welcome boost for the company.
Wednesday, J&J said the FDA has granted approval for Tremfya in moderate to severely active ulcerative colitis (UC), a form of IBD that impacts more than 1.2 million Americans. The expanded label unlocks a major market for the biologic, which first launched in 2017 to treat plaque psoriasis and added a second approval in psoriatic arthritis three years later.
The dual-acting IL-23 inhibitor is meant to neutralize inflammation by blocking IL-23 and binding to the CD64 receptor, according to the company.
In a recent UC maintenance study, 50% of patients who received subcutaneous Tremfya at its 200-mg strength every four weeks and 45.2% of those who took the 100-mg dose of the drug every eight weeks met the bar for clinical remission at the study's 44-week mark. That compared with 18.9% for those on placebo.
A further analysis showed that about two-thirds of those who achieved clinical remission were also in endoscopic remission by Week 44, meaning their intestinal lining appeared normal.
In a separate phase 3 induction study, responses to Tremfya were seen even in Week 1. In that study, 28.3% of Tremfya-treated patients achieved an early symptomatic response compared to 18.9% for those on placebo. By Week 12, the Tremfya percentage swelled to 71.7% over placebo’s 35%.
Tremfya enters the UC ring just a few months after AbbVie’s formidable Skyrizi nabbed its own nod in the disease. Like Tremfya, Skyrizi has some major shoes to fill as an heir to AbbVie’s once-dominant Humira.
But in the race for dominance in the IBD market, Skyrizi already has a leg up with a prior approval in Crohn’s disease, the second form of the disease. The drug was the first IL-23 inhibitor cleared to treat Crohn’s and last year topped Stelara in a head-to-head study.
As for J&J's newer offering, Tremfya also beat Stelara in Crohn’s treatment, according to a recent phase 3 study measuring endoscopic and clinical remission rates. The company submitted its bid for approval in that indication in June.
Tremfya pulled down $2.1 billion in sales last year, while Stelara brought in $6.9 billion.
In 2025, Amgen is slated to kick off a wave of Stelara biosimilar launches. Meanwhile, Stelara was selected as one of the 10 drugs eligible for Medicare price negotiations and will face a price cut in 2026.