The European Commission (EC) has granted approval for AbbVie’s Rinvoq (upadacitinib) to treat moderate-to-severe active ulcerative colitis (UC) in adult patients.
Treatment with upadacitinib 45mg (induction dose) and 15mg and 30mg (maintenance doses) are indicated for UC patients who have had an insufficient, lost response or were not tolerant to either standard therapy or a biologic agent.
The latest approval is based on findings from three randomised, multicentre, double-blind, placebo-controlled Phase III trials analysing the safety and efficacy of Rinvoq.
These studies included two induction studies, U-ACHIEVE induction and U-ACCOMPLISH, assessing a once-a-day dose of 45mg Rinvoq and a maintenance study, U-ACHIEVE maintenance, analysing 15mg and 30mg doses of Rinvoq given once a day.
Clinical remission according to Adapted Mayo Score was the primary endpoint of the studies while secondary endpoints comprised clinical response and mucosal healing among others.
According to the findings, the trials met the primary endpoint and all secondary endpoints with statistical significance.
Safety data from UC patients who received Rinvoq were generally in line with the previously reported safety profile of the therapy, without any new safety risks.
A selective and reversible inhibitor of Janus kinase (JAK), Rinvoq is being analysed in various immune-mediated inflammatory ailments.
In addition to UC, Phase III trials of Rinvoq in atopic dermatitis, rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, Crohn’s disease, giant cell arteritis and Takayasu arteritis are currently underway.
AbbVie research and development senior vice-president and chief scientific officer Thomas Hudson said: “Our years of experience and long-term investment in IBD research have given us invaluable insights into the challenges that ulcerative colitis patients face and a deep understanding of the ongoing need for additional treatment options to help those still suffering.
“We celebrate the approval of Rinvoq by the EC as it meaningfully expands our ability to help indicated patients in need of relief from ulcerative colitis.”
In August last year, Rinvoq received EC approval for moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above, eligible to receive systemic therapy.