FDA Approves Johnson & Johnson's Tremfya for Ulcerative Colitis

Johnson & Johnson’s (J&J) dual-acting IL-23 inhibitor, Tremfya (guselkumab), has received approval from the US Food and Drug Administration (FDA) for treating adults with moderately to severely active ulcerative colitis (UC). UC is a form of inflammatory bowel disease (IBD) impacting over a million individuals in the US. This condition leads to inflammation in the digestive tract and can cause significant colon damage. Patients with UC may endure a variety of unpredictable symptoms such as loose and more frequent bowel movements, bloody stools, abdominal pain, and loss of appetite.

Tremfya, previously approved for certain cases of plaque psoriasis and active psoriatic arthritis, functions by blocking IL-23, a critical component in the development of inflammatory diseases, and binding to the CD64 receptor. For UC treatment, Tremfya is administered initially as a 200mg dose intravenously at weeks zero, four, and eight. This is followed by a subcutaneous (SC) maintenance dose: either 100mg at week 16 and then every eight weeks, or 200mg at week 12 and every four weeks thereafter.

The FDA's approval is based on positive results from the ongoing phase 2b/3 QUASAR study. This study has been assessing Tremfya in adults with moderately to severely active UC who have not responded adequately or have shown intolerance to conventional therapy, other biologics, and/or JAK inhibitors. The findings revealed that 50% of patients receiving a 200mg SC maintenance dose of Tremfya every four weeks, and 45% of those receiving a 100mg SC dose every eight weeks, achieved the primary endpoint of clinical remission at week 44, compared to just 19% of patients treated with a placebo.

Moreover, 34% and 35% of patients receiving Tremfya 200mg and 100mg, respectively, attained endoscopic remission after one year, compared to 15% of those in the placebo group. Endoscopic remission is a significant marker as it signifies visible healing of the colon.

Christopher Gasink, vice president of medical affairs, gastroenterology, and autoantibody at J&J Innovative Medicine, highlighted the importance of new UC therapies. He noted that there is a substantial need for treatments that provide significant symptom improvement and offer the potential for remission. Gasink emphasized that the QUASAR clinical program has shown Tremfya’s high rates of endoscopic remission at one year of treatment, setting a new standard for efficacy in treating this form of IBD.

In summary, Tremfya’s FDA approval marks a significant advance in the treatment of UC, offering a new option for patients who have not responded to other treatments. The clinical data underscores its potential to achieve both clinical and endoscopic remission, thus providing meaningful relief to those suffering from this challenging condition.