Johnson & Johnson Submits Guselkumab Application to FDA for Ulcerative Colitits

Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for guselkumab (TREMFYA) for the treatment of adults with moderately to severely active ulcerative colitis (UC).¹

The potential sBLA approval from the FDA would grant a third disease indication for the interleukin 23 (IL-23) inhibitor—and the first for a gastric disease, as it was previously approved to treat both moderate to severe plaque psoriasis and active psoriatic arthritis (PsA) in adult patients.

The submission from Johnson & Johnson is supported by findings from the pivotal phase 3 QUASAR study, presented at the 2023 Digestive Disease Week (DDW) Annual Meeting. Patients with moderate to severely active UC were randomized 3:2 to either intravenous guselkumab 200 mg or placebo administered once every 4 weeks. Final data showed statistically significant and clinically meaningful improvements in UC symptoms and disease severity including endoscopic and histologic remission, and patient-reported outcomes including fatigue, with no new safety profile.

“If you look at the patient population studied in this induction study, this was a sick patient population,” study author Jessica Allegretti, MD, MPH, of Brigham & Women’s Hospital, told HCPLive at DDW 2023.² “More than half of patients randomized in each treatment group had a Mayo endoscopic score of ≥3, and about 11-13% of patients had been exposed to 3 or more advanced therapies. This is a sick population, and we are still seeing very positive results regard to treatment compared to placebo.”

Further analysis from QUASAR, presented at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting last October showed such benefit in patients with UC regardless of their history of advanced therapy intolerance at week 12.³

In a statement accompanying the news, David Lee, MD, PhD, global therapeutic area head of immunology at Johnson & Johnson, emphasized the need for therapies indicated to treat UC in patients without adequate response to or tolerance with existing drugs.¹

“TREMFYA has the potential to be a new treatment option for patients,” Lee said. “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."

References

1. ^{PRNewswire. 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. Press release. Published March 11, 2024. https://www.prnewswire.com/news-releases/johnson--johnson-submits-supplemental-biologics-license-application-to-us-fda-seeking-approval-of-tremfya-guselkumab-for-the-treatment-of-adults-with-moderately-to-severely-active-ulcerative-colitis-302085776.html?tc=eml_cleartime}
2. ^{Walter K. Jessica Allegretti, MD, MPH: An Update on the Quasar Study at DDW 2023. HCPLive. Published May 11, 2023. https://www.hcplive.com/view/allegretti-update-quasar-study-ddw-2023}
3. ^{Kunzmann K. Guselkumab Benefits Ulcerative Colitis Regardless of Patient Treatment History. HCPLive. Published October 26, 2023. https://www.hcplive.com/view/guselkumab-ulcerative-colitis-patient-treatment-history}