• Sustainability
  • DE&I
  • Pandemic
  • Finance
  • Legal
  • Technology
  • Regulatory
  • Global
  • Pricing
  • Strategy
  • R&D/Clinical Trials
  • Opinion
  • Executive Roundtable
  • Sales & Marketing
  • Executive Profiles
  • Leadership
  • Market Access
  • Patient Engagement
  • Supply Chain
  • Industry Trends

Johnson & Johnson Submits Supplemental Biologics License Application to the FDA for Tremfya in Ulcerative Colitis Treatment


Submission is based on positive results from the company’s Phase III QUASAR clinical trial, in which Tremfya (guselkumab) produced positive results treating moderately to severely active ulcerative colitis.

Man holds his belly with both hands. Stomach ache. Gastritis. Blue grey background. Image Credit: Adobe Stock Images/Fotografie-Schmidt

Image Credit: Adobe Stock Images/Fotografie-Schmidt

Johnson & Johnson (J&J) has submitted a supplemental Biologics License Application (sBLA) to the FDA seeking the approval of Tremfya (guselkumab) for adults with moderately to severely active ulcerative colitis (UC). The submission was based on positive results from the Phase III QUASAR program, which reportedly showed major improvements in symptoms, fatigue, and measures of disease activity, including endoscopic and histologic remission, for patients with UC who had an inadequate response or intolerance to conventional therapy, prior biologics, and/or JAK inhibitors.

Clinical data through a 12-week study were presented at the 2023 Digestive Disease Week (DDW) Annual Meeting, with additional results from the maintenance study expected to be unveiled at a later date.1

“Despite advances in therapy, many people living with ulcerative colitis still experience inadequate response to or do not tolerate existing therapies,” said David Lee, MD, PhD, global therapeutic area head immunology, Johnson & Johnson, in a press release. “Tremfya has the potential to be a new treatment option for patients. We look forward to working with the FDA in review of this application and remain focused on developing new therapies for those living with chronic autoimmune conditions, such as ulcerative colitis, who are experiencing persistent and debilitating symptoms.”

Tremfya was first approved by the FDA back in 2017 for the treatment of adults living with moderate to severe plaque psoriasis who are also candidates for systemic therapy or phototherapy. This approval stemmed from the results of a program that employed over 2,000 participants in the Phase III VOYAGE 1, VOYAGE 2 and NAVIGATE studies. According to the results of those studies, a majority of the participants experienced at least 90% clearer skin after 16 weeks.2

“Living with plaque psoriasis is challenging, especially the constant pain, itching and burning,” said Patti Janick, a clinical trial participant, in an earlier press release. “I am encouraged by the results I’ve experienced with Tremfya and the possibility it offers others living with plaque psoriasis to find similar relief and clearer skin.”

In 2020, Tremfya also received FDA approval for the treatment of active psoriatic arthritis. According to a press release that announced the approval, it was the first approved psoriatic arthritis treatment that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with its symptoms.3

According to statistics from the National Institute of Diabetes and Digestive and Kidney Diseases, anywhere from 600,000 to 900,000 people in the United States are currently living with UC. It is most common in individuals aged 15 to 30 years but could start at a later age. Associated complications with UC include:

  • Anemia
  • Bone issues
  • Growth and development issues in children
  • Colorectal cancer4

“Ulcerative colitis can begin gradually and become worse over time. However, it can also start suddenly,” says the National Institute of Diabetes and Digestive and Kidney Diseases. “Symptoms can range from mild to severe. In between periods of flares—times when people have symptoms—most people have periods of remission—times when symptoms disappear. Periods of remission can last for weeks or years. The goal of treatment is to keep people in remission long term.”


1. Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of TREMFYA®(guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis. Johnson & Johnson. March 11, 2024. Accessed March 12, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-supplemental-biologics-license-application-to-u-s-fda-seeking-approval-of-tremfya-guselkumab-for-the-treatment-of-adults-with-moderately-to-severely-active-ulcerative-colitis

2. JANSSEN ANNOUNCES U.S. FDA APPROVAL OF TREMFYA™ (GUSELKUMAB) FOR THE TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS. Johnson & Johnson. July 13, 2017. Accessed March 12, 2024. https://www.jnj.com/media-center/press-releases/janssen-announces-us-fda-approval-of-tremfya-guselkumab-for-the-treatment-of-moderate-to-severe-plaque-psoriasis

3. TREMFYA® (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis. Johnson & Johnson. July 14, 2020. Accessed March 12, 2024. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-approved-by-u-s-food-and-drug-administration-as-the-first-selective-interleukin-il-23-inhibitor-for-active-psoriatic-arthritis

4. Definition & Facts of Ulcerative Colitis. NIH. Accessed March 12, 2024. https://www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis/definition-facts

Related Videos
Related Content