AbbVie (NYSE:ABBV) has announced that the FDA will prolong the review period for Skyrizi (risankizumab-rzaa) to treat moderate to severe Crohn’s disease in patients 16 years and older.
The agency decided to extend the Prescription Drug User Fee Act (PDUFA) action date for the indication by three months to review additional data submitted from the sponsor related in part to an on-body injector.
FDA first approved Skyrizi, an interleukin-23 subunit p19 inhibitor, for moderate to severe plaque psoriasis in adults. Then, in January, it won an indication for adults with active psoriatic arthritis.
AbbVie developed the drug in partnership with Boehringer Ingelheim.
Last year, sales of the drug were $2.939 billion internationally.
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.
ABBV shares ticked down about 1% to $147.77.
Filed Under: Gastroenterology