New treatment for moderately to severely active Crohn’s disease approved

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new treatment for patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological agent.

Rinvoq (upadacitinib) is a janus kinase (JAK) inhibitor and this approval marks the first marketing authorisation globally for the use of upadacitinib in Crohn’s disease. This follows upadacitinib’s approval in ulcerative colitis last year.

Crohn’s disease continues to be a debilitating disease that is on the rise worldwide due to being a long-term condition with a lack of cure, the young age of onset, and low mortality. Almost half of those living with the condition have moderate or severe Crohn’s disease and over the long-term, it is associated with progressive damage to the digestive system which can then lead to surgery.

Limited new treatment options approved for Crohn’s disease

Professor James Lindsay, Consultant Gastroenterologist at the Royal London Hospital Barts Health NHS Trust, said: “There have been limited new treatment options approved for Crohn’s disease in recent years and many people struggle to stay in remission, demonstrating a clear unmet need.

“We’ve seen in clinical trials that upadacitinib has the potential to help people gain control of their disease and, with this MHRA approval, we now have an approved advanced treatment option in a new class of therapy that can be taken as a once daily pill.”

The MHRA decision was supported by data from three Phase 3 clinical trials, including two induction studies (U-EXCEED & U-EXCEL) and one maintenance study (U-ENDURE). Across all three studies, significantly more patients treated with upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response, with clinical remission measured by the patient-reported symptoms of stool frequency/abdominal pain.

Additionally, more patients receiving upadacitinib 45mg once daily at week 12 in the induction studies or 15mg and 30mg once daily at 52 weeks in the maintenance study achieved the secondary endpoint of corticosteroid-free clinical remission per stool frequency/abdominal pain compared to placebo among patients taking corticosteroids at baseline.