Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Janssen Biotech and Janssen Biologics are seeking approval for Stelara in the US and Europe for the treatment of active psoriatic arthritis.
Subscribe to our email newsletter
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."