J&J Submits sBLA To FDA for Guselkumab in Ulcerative Colitis


Individuals included in the study reported positive changes in fatigue, and disease activity displayed endoscopic and histologic remission.

Johnson & Johnson has announced submission of a supplemental Biologics License Application requesting FDA approval for guselkumab (Tremfya) to treat moderate to severe ulcerative colitis (UC).

Man holds his belly with both hands. Stomach ache. Gastritis. Blue grey background - Image credit: Fotografie-Schmidt | stock.adobe.com

Image credit: Fotografie-Schmidt | stock.adobe.com

UC is a prolonged disease of the large intestine that occurs when the lining of the colon is inflamed, developing pus and mucus, open sores, or ulcers, according to study authors. Individuals with UC could experience varying symptoms, including loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss and fatigue.

"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, in a press release.

Guselkumab is a dual-acting interleukin-23 inhibitor (IL-23i) that is intended to block IL-23, binding to CD64—a cell that produces IL-23, a main cause of inflammatory diseases. The drug previously received FDA approval in July 2017 and July 2020 to treat individuals with moderate-to-severe plaque psoriasis and psoriatic arthritis.

The study authors noted that submission for guselkumab was based on results from the randomized, double-blind, placebo-controlled, parallel group, multicenter phase 3 QUASAR study (NCT04033445). The study assessed the efficacy and safety of the treatment among individuals with moderate to severe UC who did not respond well to conventional therapy, previous biologics, and/or Janus kinase inhibitors. Additionally, the phase 2b study included a dosing range induction which was confirmed in phase 3.

The results showed significant and impactful clinical improvements in symptoms, patient-reported outcomes, and measures of disease activity, according to study authors. Individuals included in the study reported positive changes in fatigue, and disease activity displayed endoscopic and histologic remission.

Additionally, the safety results remained consistent with the approved safety profile of guselkumab, according to study authors.

The most common adverse effects with guselkumab included upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis. However, serious allergic reactions could occur when taking the drug.

"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,” said Lee, in a press release.

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. News release. March 11, 2024. Accessed March 12, 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.
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