Simponi golimumab regulatory update

FDA approved an sBLA from Johnson & Johnson for subcutaneous Simponi golimumab to treat moderately to severely active ulcerative colitis (UC) in adults who had an inadequate response to conventional therapy. In July, J&J submitted a Type II variation to EMA seeking to expand the label of subcutaneous Simponi for the indication. J&J markets subcutaneous Simponi in 67 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.

Last September, J&J submitted a BLA to FDA for the IV formulation of Simponi to treat RA (see BioCentury, Sept. 24, 2012). The IV formulation is under review for RA 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.). ...