The US Food and Drug Administration (FDA) has approved AbbVie’s approved Skyrizi (risankizumab-rzaa) for the treatment of Crohn's disease (CD) in adults.
The medicine is said to be the first and only specific interleukin-23 (IL-23) inhibitor approved for treating moderately to severely active CD in adults.
The approval follows the positive results of Skyrizi from two induction and one maintenance clinical trials.
The two 12-week induction studies were designed to assess the efficacy and safety of two doses of risankizumab, 600 mg and 1200 mg.
According to the company, a ‘significantly greater’ proportion of patients treated with Skyrizi achieved co-primary endpoints of endoscopic response and clinical remission compared to placebo.
The maintenance trial assessed the efficacy and safety of two doses of risankizumab, 600 mg and 1200 mg, compared to placebo. In the 52-week trial too, a greater percentage of patients achieved the co-primary endpoints.
AbbVie chief scientific officer and research and development senior vice-president Thomas Hudson said: “We are proud to offer the first new treatment option in six years for moderately to severely active CD, which may provide patients with a meaningful level of endoscopic improvement.
“With more than 30 ongoing or planned trials in inflammatory bowel disease, AbbVie is committed to advancing the standards of care for patients by exploring and investing in research for those living with immune-mediated, gastroenterological conditions.”
Crohn’s disease is a chronic disease that causes inflammation within the gastrointestinal (or digestive) tract leading to persistent diarrhoea and abdominal pain.
The progressive disease may worsen over time, requiring, in many cases, surgeries.
The prescribed course of Skyrizi for treating CD involves administering 600mg of medicine by intravenous infusion over at least one hour at week 0, week 4, and week 8.
This will be followed by 360mg self-administered using subcutaneous injection (SC) with an on-body injector (OBI) at week 12, and every 8 weeks thereafter.