A supplemental biologics license application (sBLA) was submitted to the FDA and a Type II Variation to the European Medicines Agency requesting clearance for Stelara (ustekinumab).
The applications included the data from two Phase 3 multicenter, randomized trials that evaluated the efficacy and safety of Ustekinumab in patients with active psoriatic arthritis.
Janssen Research & Development immunology development head Jerome Boscia said, "The efficacy and safety of STELARA, an anti-interleukin-12/23 antibody, have been evaluated in a large Phase 3 clinical development program for the treatment of active psoriatic arthritis, a disease for which tumor necrosis factor inhibitors are currently the only approved biologic therapies, and additional therapeutic options are needed."