AbbVie has revealed that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved its therapy, Rinvoq.
Also known as upadacitinib, the drug is a janus kinase (JAK) inhibitor and concerns the treatment of adult patients with moderately to severely active Crohn’s disease (CD). The patients involved would also have had a lost response, inadequate response, or were intolerant to either a biological agent or conventional therapy.
The positive decision from the MHRA was supported by results from three phases 3 clinical trials. These include two induction studies – U-EXCEED & U-EXCEL – and one maintenance study, U-ENDURE. Most significantly, more patients treated with upadacitinib achieved the target endpoints of endoscopic response and clinical remission.
In addition, more patients receiving upadacitinib 45mg once daily at week 12 in the induction studies, or 15mg and 30mg once daily at 52 weeks, during the maintenance research achieved the secondary endpoint of corticosteroid-free clinical remission per stool frequency/abdominal pain (SF/AP) compared to placebo.
Belinda Byrne, medical director at AbbVie UK, was optimistic about the news: “We are proud to be using our two decades of experience in gastroenterology in our commitment to helping better the lives of people with Crohn’s disease. We are pleased that upadacitinib can now be used to treat more people with inflammatory bowel disease.”
Professor James Lindsay, a consultant gastroenterologist at the Royal London Hospital Barts Health NHS Trust, explained: “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.”
He added: “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 worldwide impact of CD is still growing and, as a long-term, debilitating disease the search for a cure is ongoing. The condition is also associated with progressive damage to the digestive system, which can often lead to surgery.