AbbVie’s Rinvoq (upadacitinib) has been approved by the European Commission (EC) as the first oral Janus Kinase (JAK) inhibitor to treat adults with moderately to severely active Crohn’s disease, 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.
Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain.
Despite the availability of a range of treatments, not every patient achieves long-lasting remission, and the progressive damage from disease flare-ups can result in some patients requiring surgery.
Thomas Hudson, senior vice president, research and development, chief scientific officer, AbbVie, said: “The EC approval of Rinvoq in Crohn’s disease is a significant milestone in offering patients the first and only once-daily oral treatment that can provide endoscopic improvement, and sustained symptom relief, making a difference in their daily lives.
“With existing therapies, not all patients are able to achieve adequate disease control to meet their treatment goals, which is why we continue to embrace the challenge of expanding our irritable bowel disease portfolio with new treatment options.”
The company’s EC 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.
“These studies demonstrated Rinvoq’s ability to achieve key treatment targets, including endoscopic outcomes and symptomatic relief, that are critical for patients and beneficial for long-term care,” said Laurent Peyrin-Biroulet, professor of gastroenterology and head of the Inflammatory Bowel Disease group at the Gastroenterology Department, University Hospital of Nancy in France.
Rinvoq was approved in the UK for Crohn’s disease earlier this year – a decision which signalled the first marketing authorisation globally for the use of Rinvoq in this patient population.
The therapy is also already approved in the EU for adults with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis, as well as for adults and adolescents with atopic dermatitis.Πηγή: pmlive.com