FDA Approves Janssen's SIMPONI ARIA® (golimumab) for Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis in Patients Aged 2 and Older

September 30, 2020 News /BioValleyBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced that the U.S. Food and Drug Administration (FDA) has approved the anti-inflammatory drug Simponi Aria (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA) in patients aged 2 years and older).

Juvenile Idiopathic Arthritis (JIA) is a group of diseases characterized by arthritis occurring in children under 16 years of age and lasting for at least 6 weeks. In the United States, 1,000 children suffer from some type of arthritis. Polyarticular arthritis is the most common type, characterized by inflammation in more than four joints, similar to adult Rheumatoid Arthritis (RA). Juvenile Psoriatic Arthritis (jPsA) is one of the rarest subtypes of arthritis, characterized by the simultaneous presence of joint inflammation and psoriasis-related skin lesions, similar to adult PsA.

This approval is based on the GO-VIVA Phase IIIClinical Trialresults. This trial was an open-label, single-arm, multicenter study conducted in 9 countries, evaluating the pharmacokinetics, safety, and efficacy of Simponi Aria in 127 pediatric patients aged 2 to 17 years with polyarticular juvenile idiopathic arthritis (pJIA). These patients had active arthritis in ≥5 joints despite receiving methotrexate treatment for at least 2 months. The trial also included patients with juvenile psoriatic arthritis (jPsA).

In 2013, Simponi Aria was initially approved for adults with moderate to severe active rheumatoid arthritisRheumatoid Arthritis(RA), GO-VIVA was included as a postmarketing requirement under the Pediatric Research Equity Act (PREA). The purpose of the GO-VIVA trial was to extrapolate data from the pivotal Phase III clinical development program of Simponi Aria. Data extrapolation is the process of estimating future trends or effects based on prior observations. Due to the availability ofClinical TrialsGiven the limited number of pediatric patients, researchers can extrapolate data from adult patient trials to determine the potential efficacy and tolerability of the treatment in the pediatric population.

The pharmacokinetic and efficacy data for Simponi Aria in pediatric patients aged 2–17 years with pJIA were compared with data from adult RA patients in the Phase III GO-FURTHER trial of Simponi Aria, and the pharmacokinetic and efficacy outcomes in jPsA patients were compared with data from adult PsA patients in the Phase III GO-VIBRANT trial of Simponi Aria.

Dr. Mathai Mammen, Global Head of Research and Development at Janssen, stated: “FDA“The recent approval of Simponi Aria for the treatment of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) and active psoriatic arthritis (PsA) not only provides a new option for young patients with these conditions, but also adds to the growing body of therapeutic evidence for this medication. At Janssen, we remain committed to researching anti-TNF biologics for the treatment of immune-mediated diseases, and we are encouraged by the expanded treatment options now available to these patients.”

Simponi Aria (golimumab) is an intravenous infusion formulation of fully human anti-TumorTumor Necrosis Factor-α (TNF-α) Monoclonal Antibody DrugThis monoclonal antibody drug targets and neutralizes both soluble and transmembrane active forms of TNF-α, preventing their binding to TNF receptors, thereby inhibiting the biological activity of TNF. The drug significantly improves patients' symptoms, signs, and physical function, and inhibits the further progression of structural damage. The dosing regimen is 2 mg/kg body weight, administered via intravenous infusion at Week 0 and Week 4, followed by intravenous infusions every 8 weeks thereafter. Each infusion lasts 30 minutes.

In the United States, Simponi Aria was approved in 2013FDAApproved for marketing, with three adult indications approved: (1) in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoidRheumatoid Arthritis(RA) adult patients; (2) for the treatment of adult patients with active psoriatic arthritis (PsA); (3) for the treatment of adult patients with active ankylosing spondylitis (AS). To date, Simponi Aria has been approved in 24 countries worldwide, including the United States.

In China, Simponi (Xinpuni, golimumab injection) was approved for marketing in January 2018 for the treatment of adult patients with active ankylosing spondylitis (AS), as well as for use in combination with methotrexate (MTX) to treat adult patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to disease-modifying antirheumatic drugs (DMARDs), including MTX. Golimumab is a fully humanized anti-TumorTumor Necrosis Factor-alpha (TNF-α) Monoclonal Antibody Is China’s First Approved Monthly Subcutaneous Anti-Rheumatic Biologic. (Bioon.com)

Original Source: SIMPONI ARIA® (golimumab)approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older