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ULCERATIVE COLITIS BIOLOGIC
 

First biologic to treat ulcerative colitis gets US FDA okay


BY OUR PHARMA CORRESPONDENT

18 September,2005: The US Food and Drug Administration has given marketing nod for infliximab (Remicade) for the treatment of ulcerative colitis (UC). The drug will be the first biologic approved for UC, a chronic inflammatory bowel disease (IBD), Centocor, Inc., announced here. 

Remicade is now indicated for reducing signs and symptoms, achieving clinical remission and mucosal healing and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy. This is an unprecedented milestone in the treatment of moderate-to-severe UC; to date, no therapy has ever been indicated for mucosal healing and eliminating the use of corticosteroids. 

First approved in the United States for the treatment of Crohn's disease (CD) in 1998, Remicade remains the only anti-tumour necrosis factor (TNF-alpha) therapy indicated for the treatment of CD. With this new approval for the treatment of ulcerative colitis, Remicade is now the only biologic indicated for the treatment of both types of inflammatory bowel diseases, CD and UC, said a Johnson and Johnson release. 

In addition to UC and CD, Remicade is also indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. More than 600,000 patients have been treated with Remicade worldwide. This new approval for the treatment of UC continues to demonstrate the benefit of Remicade across immune-mediated inflammatory diseases. 

UC is a debilitating chronic disease affecting more than 500,000 Americans, for whom there is no medical cure, and while UC affects more people in the United States than multiple sclerosis or cystic fibrosis, general awareness of the disease is lower. 

BY OUR PHARMA CORRESPONDENT

 

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