Posted by Michael Wonder on 21 Dec 2016
Janssen submits two applications to FDA seeking approval of Simponi Aria (golimumab) for the treatment of active psoriatic arthritis and active ankylosing spondylitis
20 December 2016 - Janssen Biotech announced today the submission of two supplemental biologics license applications to the U.S. 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 alfa therapy that 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. Psoriatic arthritis and ankylosing spondylitis are chronic, systemic inflammatory conditions that combined affect more than two million Americans.
