Update regarding Skyrizi for the treatment of moderate to severe Crohn's disease in the U.S.
AbbVie has announced that the 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.
AbbVie has also filed an application with the European Medicines Agency asking for approval of Skyrizi to treat patients at least 16 years with moderate to severe Crohn’s disease.
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