FDA Extends Review Period for Skyrizi for Crohn’s Disease Indication

The FDA has extended its review period for AbbVie’s and Boehringer Ingelheim’s Skyrizi (risankizumab-rzaa) for the treatment of moderate-to-severe Crohn’s disease in patients age 16 years and older.

The FDA said Monday that it had extended the Prescription Drug User Fee Act (PDUFA) action date for the drug by three months to review additional data submitted by AbbVie for the new proposed indication, including information about the companies’ new on-body injector.

Skyrizi — an interleukin-23 inhibitor that selectively blocks a cytokine involved in inflammatory processes — was approved in the U.S. in 2019 to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Earlier this year, the FDA approved Skyrizi to treat active psoriatic arthritis in adults. Currently approved indications for Skyrizi are not affected by the review period extension.