Janssen asks FDA approval for psoriatic arthritis drug

Janssen Biotech has  submitted two Supplemental Biologics License Applications (sBLAs) to the U.S. 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.

Simponi Aria is a fully-human anti-tumor 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 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.”