Janssen has submitted two new applications to the U.S. Food and Drug Administration (FDA) seeking approval for Simponi Aria (golimumab), in combination with methotrexate, for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA) in patients age 2 and older.
While pJIA is characterized by inflammation in five or more joints, jPsA — a rarer subtype — is characterized by psoriasis-like skin irritation in addition to joint inflammation.
“All forms of JIA can be debilitating for children who live with the disease, and their parents and physicians often have a difficult time establishing a treatment plan given the limited options currently available for pediatric patients,” Alyssa Johnsen, MD, PhD, said in a press release. Johnsen is vice president and rheumatology disease area leader at Janssen Research & Development.
“At Janssen, we are focused on addressing unmet needs for all patients and are especially pleased to be taking these positive steps that could make a new treatment option available for these young patients,” Johnsen said.
Simponi Aria is an antibody-based therapy that works by blocking the activity of tumor necrosis factor alpha (TNF-alpha), a signaling molecule that promotes inflammation. By blocking TNF-alpha, the medication is intended to limit inflammation — and, by extension, pain and damage in the joints.
The therapy is a formulation of Janssen’s Simponi. But while Simponi Aria is given by intravenous (into the bloodstream) injection, Simponi is administered subcutaneously (under-the-skin). In addition, Simponi Aria requires fewer doses per year than Simponi.
The new supplemental Biologics License Applications (sBLA) for Simponi Aria in pJIA and jPsA are based on data from the open-label Phase 3 clinical trial GO-VIVA (NCT02277444). This trial included 127 children age 2–17 with pJIA or jPsA who had active disease despite at least two months of treatment with the immune system suppressant methotrexate.
GO-VIVA was designed to assess Simponi Aria’s safety, efficacy, and pharmacokinetics (how the medication moves through the body, from absorption to excretion). More specifically, given the limited number of children with JIA available to participate, the study was designed to extrapolate results from previous trials of Simponi Aria in adults with related conditions, to help determine the treatment’s benefits in a pediatric population.
The trial was a requirement by the FDA after the initial approval of Simponi Aria for adults with moderately to severely active rheumatoid arthritis in 2013.
pJIA data were compared with findings from the GO-FURTHER Phase 3 trial (NCT00973479), which tested the medication in adults with rheumatoid arthritis. Then jPsA data were compared with results from the GO-VIBRANT Phase 3 trial (NCT02181673), which was conducted in adults with psoriatic arthritis.
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