BioCentury
ARTICLE | Clinical News

Simponi golimumab regulatory update

September 30, 2013 7:00 AM UTC

The European Commission approved Simponi golimumab from Johnson & Johnson for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. EMA's CHMP issued a positive opinion for the label expansion in July (see BioCentury, Aug. 5). J&J markets subcutaneous Simponi in 70 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. FDA approved the human mAb against tumor necrosis factor (TNF) alpha for moderate to severe UC in May (see BioCentury, May 20).

In July, FDA approved a BLA for the IV formulation of Simponi as Simponi Aria to treat RA. The IV formulation is under review for the indication in the EU (see BioCentury, July 29). J&J licensed UltiMAb technology to develop golimumab from Medarex Inc., which was acquired by Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.). ...