AbbVie provides update regarding SKYRIZI® 

AbbVie today announced that the U.S. Food and Drug Administration (FDA) has extended its review period for SKYRIZI® (risankizumab-rzaa) for the treatment of moderate to severe Crohn’s disease in patients 16 years and older.

The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to review additional data submitted by AbbVie, including information about the on-body injector, for this new proposed indication. Currently approved indications for SKYRIZI are not affected by this extension.

SKYRIZI 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.

SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally. PR Newswire