AbbVie receives FDA nod for new indication of Skyrizi
AbbVie has obtained the Food and Drug Administration’s blessing for Skyrizi (risankizumab-rzaa) as the first and only specific interleukin-23 inhibitor for the treatment of adults with moderately to severely active Crohn’s disease.
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea and abdominal pain. It is a progressive disease, meaning it gets worse over time, and in many cases leads to surgery. Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease.
[Read more: AbbVie obtains FDA nod for new indication for Rinvoq]
“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,” said Thomas Hudson, senior vice president of research and development, and chief scientific officer of AbbVie. “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.”
“In both the induction and maintenance clinical trials, a significantly greater number of adult patients saw few or no symptoms and a meaningful reduction of visible signs of intestinal inflammation, compared to placebo,” said Marla Dubinsky, chief of the division of pediatric gastroenterology for the Mount Sinai Health System, and co-director of the Susan and Leonard Feinstein IBD Center at Mount Sinai. “This approval provides healthcare professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn’s disease.”
[Read more: FDA gives AbbVie approval for Qulipta]
Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of Skyrizi globally.
The medication was previously approved to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy), or treatment using ultraviolet or UV light (phototherapy), as well as active psoriatic arthritis.