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MHRA approves new treatment for ulcerative colitis

A new treatment for adult patients with moderately to severely active ulcerative colitis has been approved by the UK Medicines & Healthcare products Regulatory Agency (MHRA).

A new treatment for adult patients with moderately to severely active ulcerative colitis has been approved by the UK Medicines & Healthcare products Regulatory Agency (MHRA).

Upadacitinib (Rinvoq) is for adults who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. This approval represents upadacitinib’s fifth therapeutic indication in the UK, which include indications across gastroenterology, dermatology and rheumatology.

Upadacitinib has demonstrated efficacy in induction studies U-ACHIEVE and U-ACCOMPLISH as well as achieving the primary endpoint of clinical remission in the Phase 3 U-ACHIEVE maintenance study.

People living with ulcerative colitis experience unpredictable symptoms

Ulcerative colitis affects one in every 420, or approximately 146,000, people living in the UK and 70% of people who have active disease in a given year will have another episode in the following year.

Living with ulcerative colitis impacts all aspects of a person’s life, largely due to unpredictable symptoms such as bowel urgency, abdominal pain, rectal bleeding and bowel incontinence. The severity of symptoms and uncertainty surrounding flares can lead to a substantial burden and often cause disability for those living with the disease.

Professor James Lindsay, Consultant Gastroenterologist at the Royal London Hospital Barts Health NHS Trust, said: “People living with ulcerative colitis experience unpredictable symptoms that can make daily activities difficult. In clinical trials, upadacitinib showed its ability to rapidly control symptoms in eight weeks for many participants and sustained responses at one year. I believe these results could make a positive difference for many people with ulcerative colitis for whom previous treatment options have not worked.”

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