The FDA has expanded its approval of Skyrizi to include subcutaneous induction for adults with moderately to severely active Crohn’s disease.
The FDA has expanded its approval of Skyrizi to include subcutaneous induction for adults with moderately to severely active Crohn’s disease.
Risankizumab (Skyrizi, AbbVie) was approved in 2022 for this patient population as an IV induction regimen followed by subcutaneous maintenance.
The latest approval allows patients to start treatment from home with an on-body injector induction pack, according to a manufacturer release.
Data from the phase 3 AFFIRM trial supported the approval, the release noted. Results showed nearly twice as many patients who received the subcutaneous induction regimen