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J&J (JNJ) Seeks Expanded Use of Tremfya for Ulcerative Colitis

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Johnson & Johnson (JNJ - Free Report) has announced the submission of a supplemental biologics license application (sBLA) seeking approval of its immunology medicine, Tremfya, for a new indication — moderately to severely active ulcerative colitis (UC).

Tremfya is presently approved to treat certain patients with plaque psoriasis and active psoriatic arthritis in several countries, including the United States and the EU. The sBLA for the UC indication was based on data from the phase III QUASAR study. Data from this study showed that a significantly greater percentage of patients with moderately to severely active UC treated with Tremfya achieved clinical remission at week 44 compared with placebo.

In the past year, J&J’s shares have risen 5.3% compared with the industry’s 34.0% increase.


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Tremfya is an important drug in J&J’s immunology drugs’ portfolio and a key driver of top-line growth. The drug generated sales of $3.1 billion in 2023, up almost 18% year over year. J&J expects Tremfya to be a $5 billion product with potential approvals in inflammatory bowel disease (IBD) indications, Crohn’s disease (CD) and UC. Tremfya is in phase III development for the CD indication.

In recent years, there has been a surge in the prevalence of gastrointestinal disorders like UC and CD due to genetic factors, environmental factors and lifestyle changes. In addition, immune system irregularities, higher diagnosis rates, increased focus on early diagnosis and favorable reimbursement policies in developed countries are driving demand for IBD treatments. According to a report by Fortune Business Insights, the global IBD market is expected to witness a CAGR of 5.7% from 2023 to 2030.

Several big drugmakers have products to treat UC and CD and are also developing new medicines with novel mechanisms of action to help patients achieve long-term clinical remission. Some other key players in the IBD market are AbbVie, Eli Lilly, Pfizer, Novartis, Merck (MRK - Free Report) , Sanofi (SNY - Free Report) , Gilead and Amgen. Some of these companies have also in-licensed rights to IBD candidates with improved clinical profiles from smaller drugmakers in the past two to three years.

For example, in June 2023, Merck acquired small biotech Prometheus Biosciences, which added tulisokibart/MK-7240 to its pipeline. MK-7240, a novel TL1A inhibitor, is being developed for the treatment of immune-mediated diseases, including UC, CD and other autoimmune conditions. In October, Sanofi in-licensed rights to jointly develop and commercialize Teva Pharmaceutical’s (TEVA - Free Report) IBD candidate, TEV’574, which is also an anti-TL1A therapy. Teva’s TEV’574 is presently being evaluated in a phase IIb study for UC and CD.

Zacks Rank

J&J currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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