New drug for arthritis in childhood! FDA approves Johnson and Johnson anti-inflammatory drug Simponi Aria :Treatment pJIA and jPsA!

September 30, 2020 // -- Johnson and Johnson (JNJ)'s Janssen Pharmaceuticals recently announced that the U.S. Food and Drug Administration (FDA) has approved the anti-inflammatory drug Simponi Aria (golimumab, Golimu monoantigen) for the treatment of polyarthritis (pJIA) and young psoriasis arthritis (jPsA) in patients 2 years of age and older.
Young Iddigy Arthritis (JIA) is a disease characterized by arthritis that occurs in a group of children aged <16 for at least six weeks, and in the United States, 1,000 children suffer from some type of arthritis.
arthritis is the most common, characterized by inflammation of more than four joints, similar to human rheumatoid arthritis (RA).
early childhood psoriasis arthritis (jPsA) is one of the rarest arthritis subshapes, characterized by both arthritis and psoriasis-related dermatological damage, similar to adult PSA.
approval is based on the results of the GO-VIVA PHASE III clinical trial.
The trial, an open-label, one-arm, multi-center study conducted in nine countries, assessed the pharmacodynamics, safety and efficacy of Simponi Aria in 127 pJIA children aged 2-17 who were treated with methotrexate for at least two months but had active arthritis in ≥5 joints.
the trial also included jPsA patients.
in 2013, after Simponi Aria was first approved for moderate to severe active rheumatoid arthritis (RA) in adults, GO-VIVA was included in the post-market requirement under the Pediatric Research Equity Act (PREA).
the GO-VIVA trial was to push data from the key Phase III clinical development project of Simponi Aria.
data extraterred is the process of estimating future trends or impacts based on previous observations.
limited number of pediatric patients available for clinical trials, researchers can push data from adult patient trials to determine the potential efficacy and tolerance of treatment for pediatric populations.
Simponi Aria's pharmacodynamics and efficacy data in pJIA pediatric patients aged 2-17 years were compared with adult RA patient data from the Simponi Aria Phase III GO-FURTHER trial, pharmacological dynamics and efficacy results in jPsA patients were compared with adult PSA patient data from the Simponi Aria III GO-VIBRANT trial. Dr. Mathai Mammen, global head of research and development at
Jansen, said, "The FDA's latest approval of Simponi Aria for the treatment of active pJIA and active PSA pediatric patients not only opens up new options for young patients with these diseases, but also adds to the growing body of treatment evidence for this drug."
at Janssen, we have been working on anti-TNF biologics to treat immunometric diseases and are encouraged by the expanded treatment options available to these patients.
"Simponi Aria (golimumab) is an all-human anti-tumor necrosis agent in the intravenous infusion form α (TNF-α) monoclonal antibody drug that targets and is soluble TNF-α, a sexual and transfilm active form, inhibits the biological activity of TNF by preventing its binding to TNF receptors, which can significantly improve patient symptoms and signs, physical activity, and inhibit the further development of structural damage.
the dose of the drug is 2 mg/kg body weight, intravenous infusion at weeks 0 and 4, followed by intravenous administration every 8 weeks, the entire infusion process takes 30 minutes.
U.S., Simponi Aria was approved by the FDA in 2013 for three adult adaptations: (1) combined methotrexate (MTX) to treat moderate to severe active rheumatoid arthritis (RA) Adult patients; (2) for the treatment of active psoriasis arthritis (psoriatic arthritis, PsA) adult patients; (3) for the treatment of active orthopaedic spina brysitis (ankylosing spondylitis, AS) adult patients.
, Simponi Aria has been ratified by 24 countries around the world, including the United States.
In China, Simponi (Simpni, Golimu monoantigenic injections) was approved in January 2018 for the treatment of adult patients with active orthopedic scoliosis (AS) and for the treatment of moderate to severe active rheumatoid arthritis (RA) adult patients, including methotrexate (MTX), which improves the effectiveness of rheumatoid drugs.
Golimu monoantigen is an all-humanized anti-tumor necrotizing agent (TNF-α) monoclonal antibody and is the first approved monthly subsurfic injection of anti-rheumberizer biologics in China.
origin of the original text: SIMPONI ARIA ® (golimumab) approved by the U.S. Food and Drug Administration for PolyAlticIonalage Idiopathic Arthritis and Extension of Its Active Psori Arthritis Insging in Patients 2 Years of Age and Older.