.gif)
Janssen Biotech, Inc. (Janssen) announced the submission of two Supplemental Biologics License Applications (sBLAs) to the US Food and Drug Administration (FDA) seeking approval of Simponi Aria (golimumab) for the treatment of adults living with active psoriatic arthritis and the treatment of adults living with active ankylosing spondylitis (AS).
Simponi Aria is a fully-human anti-tumour necrosis factor (TNF)-alpha therapy that is currently approved as a 30-minute intravenous infusion for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate. Psoriatic arthritis and ankylosing spondylitis are chronic, systemic inflammatory conditions that combined affect more than two 1-3 million Americans.
“At Janssen, we are committed to addressing the unmet medical needs of patients living with psoriatic arthritis and ankylosing spondylitis through the discovery and development of innovative therapeutics,” said Newman Yeilding, M.D, head of immunology development, Janssen Research & Development, LLC. “We understand the need for additional treatment options for patients and their healthcare providers and hope to make Simponi Aria available for those in need.”
Data from two separate phase 3 studies evaluating the efficacy and safety of Simponi Aria 2 mg/kg given as an intravenous infusion every eight weeks after two starter doses at weeks 0 and 4 in the treatment of adults living with active psoriatic arthritis (GO-VIBRANT) and active ankylosing spondylitis (GO-ALIVE) served as the basis for the submissions. Results from the GO-ALIVE study were presented at the 2016 ACR/ARHP Annual Meeting and results from the GO-VIBRANT study are planned for presentation at an upcoming scientific congress.
Simponi Aria is an infusible, fully human anti-TNF-alpha monoclonal antibody that targets both soluble and transmembrane bioactive forms of TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. By binding with and blocking TNF-alpha, Simponi Aria helps control inflammation. Simponi Aria is approved for the treatment of adult patients with moderately to severely active RA with the medicine methotrexate.
