FDA Expands Approval of Janssen’s Stelara for Pediatric Psoriatic Arthritis
The FDA has expanded its approval to Janssen’s Stelara (ustekinumab) for treatment of pediatric patients six years and older with psoriatic arthritis.
The injection drug was first approved in 2009. The other approved indications include adult patients with active psoriatic arthritis and moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
The expanded approval was supported by positive results from multiple phase 3 studies in adult patients with active psoriatic arthritis and adult and pediatric patients with moderate-to-severe plaque psoriasis.
Stelara is a monoclonal antibody that selectively inhibits two cytokines, interleukin-12 and interleukin-23, which play an important role in several autoimmune diseases.
Ustekinumab
Ustekinumab, sold under the brand name Stelara is a monoclonal antibody medication developed by Janssen Pharmaceuticals, for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, targeting both IL-12 and IL-23. Ustekinumab is approved to treat Crohn's disease in the United States, Israel, Australia, and the European Union (EU), and ulcerative colitis in the US, and in the EU to patients who have not responded to more traditional treatments. It was found not effective for multiple sclerosis.
August 2, 2022
