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MHRA Approves RINVOQ®▼ (upadacitinib) as First Oral Advanced Therapy to Treat Adults with Moderately to Severely Active Crohn's Disease

MHRA Approves RINVOQ®▼ (upadacitinib) as First Oral Advanced Therapy to Treat Adults with Moderately to Severely Active Crohn's Disease

- This approval for Great Britain marks the first marketing authorisation globally for the use of upadacitinib, a janus kinase (JAK) inhibitor, in Crohn's disease (CD). This follows upadacitinib's approval in ulcerative colitis last year

- Over 155,000 adults are estimated to live with CD in the UK, 1,2 a chronic, progressive condition of the digestive system3,4 that causes a significant physical, emotional and economic burden on people living with it5,6

- In the UK, people with CD were hospitalised over 120,000 times from 2020-20217 and many people with CD do not achieve long-term remission with existing therapies8

- Approval based on three Phase 3 clinical trials demonstrating upadacitinib achieved the coprimary endpoints of clinical remission and endoscopic response at week 12 and week 52 (p<0.001 vs placebo) 9,10,11,12

MAIDENHEAD, UK, 01 February 2023 – AbbVie (NYSE: ABBV) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved RINVOQ® (upadacitinib), a janus kinase (JAK) inhibitor, for the treatment of adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological agent. 12

CD 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. 13 Almost half of those living with the condition have moderate or severe CD1,14,15 and over the long-term, CD is associated with progressive damage to the digestive system16 which can then lead to surgery. 8

“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,” said Professor James Lindsay, Consultant Gastroenterologist at the Royal London Hospital Barts Health NHS Trust. “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 (SF/AP).9,10,11,12 Additionally, more patients receiving upadacitinib 45 mg once daily at week 12 in the induction studies or 15 mg and 30 mg once daily at 52 weeks in the maintenance study achieved the secondary endpoint of corticosteroid-free clinical remission per SF/AP compared to placebo among patients taking corticosteroids at baseline.9,10,11,12 

The safety results of upadacitinib in U-EXCEED, U-EXCEL and U-ENDURE were generally consistent with the known safety profile of upadacitinib in other licenced indications. 9,10,11,12

“We are proud to be using our two decades of experience in gastroenterology in our commitment to help better the lives of people with Crohn’s disease,” said Belinda Byrne, Medical Director, AbbVie UK. “We are pleased that upadacitinib can now be used to treat more people with inflammatory bowel disease”.

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Last Updated: 03-Feb-2023