ARTICLE | Clinical News

Simponi golimumab regulatory update

November 15, 2010 8:00 AM UTC

Johnson & Johnson's Centocor Ortho Biotech Inc. subsidiary submitted an sBLA to FDA to expand the label for Simponi golimumab to include inhibiting the progression of structural damage, and maintenance of improvement in signs and symptoms and physical function in the treatment of patients with active psoriatic arthritis. The human mAb against tumor necrosis factor (TNF) alpha is already approved to treat moderate to severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis. Centocor licensed UltiMAb technology to develop golimumab from Medarex Inc., which was acquired by Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.). ...