EC Approves J&J's Tremfya for Ulcerative Colitis

The European Commission (EC) has recently approved Johnson & Johnson's Tremfya (guselkumab) for the treatment of adults with moderate to severe ulcerative colitis (UC), specifically targeting those who have not experienced sufficient improvement with standard therapies or biological treatments. Ulcerative colitis is a persistent inflammation of the colon, and this authorization marks a significant advancement in its management.

Tremfya, a product developed by J&J, stands out as the first fully-human, dual-acting inhibitor targeting the interleukin-23 (IL-23) p19 subunit. IL-23 is a prominent factor in various immune-mediated conditions, including ulcerative colitis. The EC's decision to approve Tremfya is supported by data derived from the comprehensive QUASAR program. This research initiative encompasses a Phase IIb trial focused on determining optimal induction dosages and Phase III trials evaluating both the initiation and maintenance phases of treatment. These clinical studies concentrated on assessing the safety and efficacy of guselkumab in patients with UC who are the intended beneficiaries of the treatment.

The findings were notable: 45% of participants receiving a 100mg subcutaneous dose every eight weeks and 50% of those on a 200mg dose every four weeks achieved clinical remission by week 44. In stark contrast, the placebo group demonstrated a remission rate of only 19%. Additionally, endoscopic normalisation—an important indicator of healing in UC—was achieved in 35% of patients on the 100mg dose and 34% on the 200mg dose, compared to just 15% in the placebo group. Importantly, the safety profile of Tremfya in treating UC is consistent with its known safety in other conditions, such as psoriasis and psoriatic arthritis.

Mark Graham, the lead for the immunology therapeutic area at J&J's innovative medicine division in the EMEA region, underscored the urgent need for new UC treatments. He highlighted the potential of Tremfya to significantly improve UC symptoms and promote remission, thereby enhancing patients' quality of life both physically and mentally.

For the treatment regimen, guselkumab is initially administered as a 200mg intravenous dose at weeks zero, four, and eight to induce remission. For maintenance, a subcutaneous 100mg dose is recommended at week 16, followed by doses every eight weeks. Should the initial induction not yield adequate results, a more frequent 200mg subcutaneous dose every four weeks may be considered.

With this approval, Tremfya now has three indications in the European Union. Initially sanctioned in November 2017 for treating moderate-to-severe plaque psoriasis, it later gained approval in November 2020 for active psoriatic arthritis. The EC is currently deliberating on further expanding guselkumab's marketing authorisation to include treatment for Crohn’s disease, another inflammatory bowel condition, with a decision anticipated in 2025.

In a related development, Janssen-Cilag International's Darzalex (daratumumab) has also received an extended indication from the EC. This approval pertains to a subcutaneous formulation for newly diagnosed multiple myeloma in adults, further showcasing the EC's ongoing commitment to advancing treatments for complex medical conditions.