The MHRA has approved the first marketing authorisation globally for the use of RINVOQ®▼ (upadacitinib) in Crohn’s disease.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved RINVOQ®▼ (upadacitinib), the first oral advanced therapy for adults with moderately to severely active Crohn’s disease (CD).
This approval for Great Britain marks the first marketing authorisation globally for the use of upadacitinib in CD.
Treating Crohn’s disease
“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,” shared Professor James Lindsay, Consultant Gastroenterologist at the Royal London Hospital Barts Health NHS Trust.
AbbVie’s janus kinase (JAK) inhibitor is indicated for Crohn’s disease patients who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological agent. “with this MHRA approval, [this new] treatment option in a new class of therapy can be taken as a once daily pill,” stated Professor Lindsay.
Data that supported the MHRA’s decision
The MHRA’s regulatory decision was supported by data from three Phase III clinical trials (NCT03345836, NCT03345849, NCT03345823). “We’ve seen in clinical trials that upadacitinib has the potential to help people gain control of [Crohn’s] disease,” added Professor Lindsay.
Across all the three Phase III studies, significantly more patients treated with upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response.
More Crohn’s disease 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. This was defined per patient-reported symptoms of stool frequency/abdominal pain (SF/AP), compared to placebo among patients taking corticosteroids at baseline.
The safety results of upadacitinib the Phase III trials were generally consistent with the known safety profile of upadacitinib in other licenced indications.
“We are pleased that upadacitinib can now be used to treat more people with inflammatory bowel disease,” commented Belinda Byrne, Medical Director, AbbVie UK.
The MHRA’s approval in CD follows upadacitinib’s approval in ulcerative colitis (UC) last year.
▼ This medicine is subject to additional monitoring.
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