It is said to be the first indication for Rinvoq in gastroenterology and the FDA approval in the indication is supported by efficacy and safety data from three placebo-controlled Phase 3 clinical trials
AbbVie corporate headquarters. (Credit: AbbVie Inc.)
US-based drugmaker AbbVie has received approval from the US Food and Drug Administration (FDA) for Rinvoq (upadacitinib) to treat a type of ulcerative colitis (UC) in adults.
The drug was indicated for moderately to severely active UC in adults, with inadequate response or intolerance to one or more tumour necrosis factor (TNF) blockers.
The US health agency recommended a 45mg dose for use in adult patients, 15mg for maintenance treatment, and 30mg for patients with refractory, severe or extensive disease.
Rinvoq is a selective JAK inhibitor, discovered and developed by AbbVie, to treat various immune-mediated inflammatory diseases.
The drug was initially approved in 2019, for four indications across gastroenterology, dermatology and rheumatology.
It is currently being studied in ongoing Phase 3 trials in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, giant cell arteritis and Takayasu arteritis.
AbbVie research and development senior vice president, chief scientific officer Thomas Hudson said: “There remains an unmet need for patients with moderately to severely active UC, who suffer from debilitating symptoms that are often unpredictable and burdensome.
“With the approval of Rinvoq as a new treatment option, AbbVie continues our leadership in advancing research that can help impact the lives of people living with ulcerative colitis.”
AbbVie said that it is the first indication for Rinvoq in gastroenterology and is supported by efficacy and safety data from three placebo-controlled Phase 3 clinical trials.
The induction studies U-ACHIEVE and U-ACCOMPLISH used Rinvoq 45mg once daily dose for eight weeks, and the U-ACHIEVE maintenance study used 15mg or 30mg once daily dose through 52 weeks.
In all three studies, patients treated with Rinvoq achieved clinical remission at eight and 52 weeks, which is the primary endpoint based on the modified Mayo Score (mMS).
Also, the studies met all ranked secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), said the company.
Rinvoq is said to cause serious side effects, including infections, elevated risk of death in older people, cancer and immune system problems, risk of major cardiovascular events, blood clots, serious allergic reactions, and tears in the stomach or intestines.