EC approves J&J's Tremfya for adult ulcerative colitis treatment

Johnson & Johnson (J&J) has recently received approval from the European Commission (EC) for its IL-23 inhibitor, Tremfya (guselkumab), to be used in the treatment of adults suffering from ulcerative colitis (UC). This approval is specifically for those patients who have moderate to severe cases of UC and have not responded well or have developed intolerance to conventional or biologic therapies.

Ulcerative colitis is an inflammatory bowel disease (IBD) affecting over 2.5 million individuals across Europe. The condition is characterized by unpredictable symptoms such as frequent and loose bowel movements, blood in the stools, abdominal discomfort, and reduced appetite. Tremfya, which functions by blocking IL-23, a key element in the progression of inflammatory conditions, is already sanctioned in the EU for conditions like plaque psoriasis and psoriatic arthritis.

For addressing UC, Tremfya is administered initially as a 200mg dose intravenously at the start and then at weeks four and eight. This is followed by a subcutaneous maintenance dose of 100mg at week 16, continuing every eight weeks. Alternatively, patients not responding adequately to this initial treatment may receive a 200mg dose every four weeks after week 12.

The EC's approval of Tremfya for UC treatment was influenced by recommendations from the European Medicines Agency's human medicines committee, backed by evidence from the QUASAR program. This program included a phase 2b induction dose-ranging study and phase 3 studies for induction and maintenance. In the maintenance phase, 45% of patients on a 100mg subcutaneous maintenance dose every eight weeks and 50% of patients on a 200mg dose every four weeks achieved the primary goal of clinical remission by week 44. This was significantly better than the 19% remission rate in those receiving a placebo.

Mark Graham, a senior director at J&J, highlighted the urgent need for new UC treatments that significantly improve symptoms and offer remission possibilities, including both clinical remission and endoscopic healing of the colon. He expressed optimism about Tremfya setting a new benchmark in UC treatment.

Additionally, the EC is reviewing another recommendation for Tremfya's use in treating Crohn’s disease, another major form of IBD.