In a press release dated April 19, 2004, Centocor announced that the FDA has accepted the sBLA for it’s TNF-a therapy, Remicade® (infilximab), for the use in the treatment of Ankylosing Spondylitis. Thus, Remicade has moved one step closer to FDA approval for treating AS.

Currently, Remicade is the only biologic indicated for the treatment of rheumatoid arthritis and Crohn’s disease. If approved, Remicade would be the second TNF-a therapy that has the FDA stamp of approval for AS along with Enbrel® (entanercept), a biologic by Amgen & Wyeth.

According to the press release, the submission of Remicade for AS is based primarily on the results of the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial, which “showed that patients with active AS achieved improvement in signs and symptoms associated with their disease.”