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AbbVie’s Rinvoq approved by MHRA for Crohn's disease

Over 155,000 adults in the UK are estimated to have the disease, with 40% of them having moderate or severe symptoms


AbbVie’s Rinvoq (upadacitinib) has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults with moderately to severely active Crohn's disease (CD), the company announced.

The authorisation is specifically for patients who have had an inadequate response, lost response or were intolerant to conventional therapy or a biological agent.

CD is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain.

It is estimated that there are over 155,000 adults living with the condition in the UK, 40% of which experience moderate or severe cases.

Despite the availability of a range of treatments, not every patient with CD achieves long-lasting remission, AbbVie reports, and the progressive damage from disease flare-ups results in over 20% of patients undergoing surgery within five years of diagnosis.

“There have been limited new treatment options approved for CD 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.

With this MHRA approval, which marks the first marketing authorisation globally for the use of Rinvoq in CD, patients will now have access to a new class of therapy that can be taken as a pill once a day.

The company’s application was supported by data from three phase 3 trials, including two induction studies and one maintenance study.

Across all three studies, significantly more Rinvoq-treated patients 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, a higher proportion of patients receiving a once daily 45mg dose of Rinvoq 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 per SF/AP compared to placebo.

Belinda Byrne, medical director at AbbVie UK, said: “We are proud to be using our two decades of experience in gastroenterology in our commitment to help better the lives of people with CD.

“We are pleased that [Rinvoq] can now be used to treat more people with inflammatory bowel disease.”

Article by
Emily Kimber

2nd February 2023

From: Regulatory



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