MHRA approves RINVOQ (upadacitinib) as first oral advanced therapy to treat adults with moderately to severely active Crohn’s disease

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved AbbVie’s 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.

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

“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).

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.

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.

“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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