Biotech Values

[DewDiligence]

FDA approves ABBV’s Skyrizi for first-line ulcerative colitis:

https://www.prnewswire.com/news-releases/us-fda-approves-skyrizi-risankizumab-rzaa-for-ulcerative-colitis-expanding-abbvies-portfolio-across-inflammatory-bowel-disease-302176163.html

• Approval supported by two Phase 3 clinical trials that evaluated SKYRIZI for the treatment of moderate to severe ulcerative colitis: a 12-week induction study, INSPIRE,1 and a 52-week maintenance study, COMMAND

• Data showed that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, a key secondary endpoint

• SKYRIZI is the first IL-23 antagonist approved for both ulcerative colitis and Crohn's disease

ABBV’s Rinvoq, which is oral, is also approved in UC and Crohn’s disease following first-line treatment with a TNF-a agent such as Humira (#msg-171942039). Thus, Skyrizi and Rinvoq together give ABBV a bruising one-two punch in IBD, which accounts for about 40% of the overall market addressed by these agents (and Humira).

ABBV says Skyrizi and Rinvoq will have combined worldwide sales of $27B by 2027, several billion more than the peak annual sales attained by Humira.