Janssen Biotech announced that the Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of patients aged ≥12 years with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
The expanded approval was supported by data from a Phase 3 study that evaluated the safety and efficacy of subcutaneous Stelara in adolescents aged ≥12 years. At the Week 12 primary endpoint (Physician’s Global Assessment [PGA] score 0 or 1), at least two-thirds of patients treated with Stelara were responders after 2 doses at Weeks 0 and 4. Safety data in patients treated with Stelara were comparable with those observed in adult plaque psoriasis studies.
Stelara, a fully human interleukin (IL)-12 and IL-23 antagonist, is already approved to treat adults with moderate or severe psoriasis who may benefit from systemic or phototherapy. It is also indicated to treat adults aged ≥18 years with active psoriatic arthritis, alone or in combination with methotrexate, and for the treatment of active Crohn’s disease in adults who have failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker or, failed or were intolerant to treatment with ≥1 TNF blockers.
Stelara is available as 45mg/0.5mL and 90mg/mL solution for subcutaneous injection, and as 130mg/26mL strength solution for intravenous infusion in certain single-use vials and single-use prefilled syringes.
For more information call (800) 526-7736 or visit Stelara.com.