Janssen Reports Submission of Two sBLA to the US FDA for SIMPONI ARIA (golimumab) to Treat Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis
Shots:
- The submissions are based on P-III GO-VIVA study involves assessing of SIMPONI ARIA in 127 patients aged 2-17yrs. with active pJIA having arthritis in 5or more joints- despite current treatment with methotrexate for at least two mos.
- The focus of the study is to evaluate PK safety & efficacy of the therapy in pediatric pJIA patients and the data of pJIA patients were compared to its P-III GO-FURTHER study of SIMPONI ARIA in adult patients with RA and the data of jPsA patients was compared to the results of P-III GO-VIBRANT study in adults patients with PsA
- SIMPONI ARIA is an anti-TNF-alpha mAb targeting both soluble and transmembrane bioactive forms of human TNF-alpha and is administered via a 30-min infusion- approved for moderately to severely active RA- active PsA or active AS
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