Johnson & Johnson has announced that the US Food and Drug Administration has approved its TREMFYA (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

A fully human monoclonal antibody, TREMFYA offers dual action by blocking IL-23 and binding to CD64.

TREMFYA is administered intravenously with a 200mg induction dose at weeks zero, four and eight, followed by a maintenance dosage either subcutaneously every eight weeks or every four weeks, depending on the dosage.

Patients or caregivers can administer the subcutaneous maintenance dose after receiving training.

The FDA’s decision was informed by the results of the Phase II/III QUASAR study, which demonstrated the efficacy and safety of TREMFYA in UC patients who had not responded adequately to other treatments.

50% of the subjects receiving TREMFYA SC 200mg every four weeks, and 45% of those on a 100mg dose every eight weeks, achieved clinical remission at week 44, meeting the primary endpoint. This is a significant improvement compared to the 19% remission rate in placebo-treated patients.

34% and 35% of patients achieved endoscopic remission with the 200mg and 100mg doses respectively, compared to 15% of placebo-treated patients.

The trial results also re-inforced the established safety profile of TREMFYA.

TREMFYA now has three indications, having been previously approved for the treatment of moderate-to-severe plaque psoriasis in July 2017 and active psoriatic arthritis in July 2020.

Johnson & Johnson innovative medicine gastroenterology and autoantibody medical affairs vice-president Christopher Gasink stated: “There is a significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission, both overall clinical remission as well as delivering visible healing of the colon through endoscopic remission.

“In the QUASAR clinical programme, TREMFYA demonstrated high reported rates of endoscopic remission at one year of treatment, continuing to raise the bar for efficacy in the treatment of this inflammatory bowel disease.”

In August 2024, the company’s Rybrevant (amivantaZmab-vmjw) plus Lazcluze (lazertinib) secured US FDA approval as a first-line treatment for patients with some types of non-small cell lung cancer.