FDA Expands AbbVie’s Skyrizi Approval to Include Crohn’s Disease

The FDA expanded its approval for AbbVie’s blockbuster monoclonal antibody, Skyrizi (risankizumab-rzaa), this time for adult patients with moderately to severely active Crohn’s disease.

An interleukin-23 (IL-23) inhibitor, Skyrizi is also approved for treatment of active psoriatic arthritis and for patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The approval was supported by results from three pivotal studies in which participants taking Skyrizi saw significant improvements in clinical remission compared with participants given a placebo.

AbbVie earned more than $2.9 billion in Skyrizi sales in 2021.