BioCentury
ARTICLE | Clinical News

Simponi golimumab regulatory update

July 23, 2012 7:00 AM UTC

Johnson & Johnson submitted an sBLA to FDA and a Type II variation to EMA seeking to expand the label of subcutaneous Simponi golimumab to include treatment of moderately to severely active ulcerative colitis in adults who had an inadequate response to conventional therapy. J&J markets a subcutaneous formulation of Simponi in 52 countries for rheumatologic indications, including the U.S. and EU, where the drug is approved for moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. J&J plans to submit a BLA to FDA for the IV formulation of Simponi to treat RA this year. The IV formulation is under review in the EU. J&J licensed UltiMAb technology to develop the human mAb against tumor necrosis factor (TNF) alpha from Medarex Inc., which was acquired by Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.). ...