US FDA Approves STELARA in Children with Active PsA


The US Food and Drug Administration (FDA) has approved STELARA produced by Janssen Pharmaceutical Company of Johnson & Johnson, for the treatment of pediatric patients older than six years with active psoriatic arthritis (PsA). This rare disease affects around 8 percent of children and adolescents with chronic inflammatory arthritis.

STELARA is a fully human monoclonal antibody, which selectively inhibits both intelukin IL-12 and IL-23, which are two cytokines thought to play an important role in modifying the overactive inflammatory response in many autoimmune diseases. STELARA is mainly administered as an injection dosed four times every year after two beginning doses for the treatment of pediatric patients over six years suffering with active PsA.

Terence Rooner, vice president, rheumatology and maternal fetel disease area at Janssen Research & Development, LLC, said they know active PsA is a challenging inflammatory disease and the symptoms, such as skin lesions and swollen joints, can significantly vary in severity and presentation.

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He also said that with this approval of STELARA, they are pleased to help address the needs of young patients and also provide physicians with a treatment option that has an established track record of efficacy and safety.

The US FDA’s approval was based on the pharmacokinetic (PK) data, and the efficacy and safety profile of STELARA in multiple Phase 3 studies in pediatric and adult patients with medium-to-serious plaque PsO, and adult patients with active PsA.