Simponi ARIA cleared by US FDA

US health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen Biotech subsidiary has received US Food and Drug Administration approval for Simponi ARIA (golimumab) for infusion for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.

Simponi, which is approved for the treatment of rheumatoid arthritis and ulcerative colitis, generated first-quarter 2013 sales of $175 million for the company, which notes that Simponi ARIA is the first Anti-TNF infusion therapy approved in more than a decade for patients living with moderately to severely active RA.

Simponi ARIA, the only fully-human anti-tumor necrosis factor (TNF)-alpha infusible therapy, has been shown to significantly improve signs and symptoms and physical function, and inhibit the progression of structural damage. The Simponi ARIA dose regimen is mg/kg given as an intravenous infusion at weeks 0 and 4, then every 8 weeks thereafter. Around 1.3 million people in the USA are living with RA, a chronic, systemic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation, and in some cases, joint destruction and disability.