Janssen seeks approval of Simponi Aria for psoriatic arthritis and ankylosing spondylitis

HORSHAM, Pa. — Janssen Biotech submitted two Supplemental Biologics License Applications to the U.S. Food and Drug Administration seeking approval of its Simponi Aria (golimumab) for the treatment of adults living with active psoriatic arthritis and the treatment of adults living with active ankylosing spondylitis. Psoriatic arthritis and ankylosing spondylitis are chronic, systemic inflammatory conditions that combined affect more than 2 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 and Development. "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."

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. It is currently approved as a 30-minute intravenous infusion for the treatment of adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate.

According to Horsham-based Janseen Biotech, 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 zero 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.

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.