The US Food and Drug Administration (FDA) has accepted an indication extension filing from Johnson & Johnson (J&J; NYSE: JNJ) for its IL-23p19-subunit inhibitor Tremfya (guselkumab) as a potential treatment for moderately to severely active ulcerative colitis (UC). The regulatory body will now review data from a late-stage study that demonstrated the therapy’s effectiveness in improving symptoms, patient-reported outcomes, and disease activity, with a notable increase in clinical remission rates at week 44 when compared to placebo.
The safety profile of Tremfya, as observed in the study, was found to be consistent with that reported in its already approved indications, which include plaque psoriasis (PsO) and psoriatic arthritis (PsA). This consistency in safety profile, along with the positive efficacy data, will be crucial as the FDA considers the extension of Tremfya’s use to include UC patients.- Flcube.com
