AbbVie have announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved RINVOQ® (upadacitinib)* for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 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.
UC affects 1 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. Upadacitinib provides an additional treatment option for adults who continue to have moderately to severely active disease despite treatment with conventional or biologic therapies.
Living with UC 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.
“People living with ulcerative colitis experience unpredictable symptoms that can make daily activities difficult,” said Professor James Lindsay, Consultant Gastroenterologist at the Royal London Hospital Barts Health NHS Trust. “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.”
“There remains an unmet need for people with moderately to severely active ulcerative colitis, who often experience debilitating symptoms that are unpredictable and burdensome,” said Belinda Byrne, Medical Director, AbbVie UK. “With the approval of upadacitinib as a new treatment option, AbbVie continues its leadership in advancing research that can help impact the lives of people living with ulcerative colitis.”
The safety and efficacy profile of upadacitinib has been evaluated in adults with moderately to severely active UC. Safety results of upadacitinib were consistent with the known safety profile of upadacitinib in other licenced indications, with no new important safety risks observed. In the placebo-controlled UC induction and maintenance clinical trials, the most commonly reported adverse events with upadacitinib 45 mg, 30 mg or 15 mg were upper respiratory tract infection, increased blood creatine phosphokinase, acne, neutropenia, rash, herpes zoster, hypercholesterolaemia, folliculitis, herpes simplex and influenza.
*This approval is without prejudice to the final conclusions of the ongoing referral procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data.