SIMPONI® (golimumab) Receives FDA Approval for Ulcerative Colitis

Crohn's Disease Forum

Help Support Crohn's Disease Forum:

nogutsnoglory

Moderator
Joined
Sep 23, 2009
Messages
8,908
SIMPONI® (golimumab) Receives FDA Approval for Ulcerative Colitis

"Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI® (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine. SIMPONI is the first and only subcutaneously administered anti-tumor necrosis factor (TNF)-alpha therapy approved to induce and maintain clinical response and improve endoscopic appearance of the mucosa during induction. In addition, SIMPONI is indicated to induce clinical remission and achieve and sustain clinical remission in induction responders. As many as 700,000 people in the United States are affected by UC1, a chronic inflammatory bowel disease (IBD) marked by inflammation and ulceration of the innermost lining of the colon."

Full article: http://www.ccfa.org/news/simponi.html
 
Back
Top