Janssen’s ulcerative colitis drug approved by US FDA

Janssen Biotech, one of Johnson & Johnson's pharma companies, has announced the FDA approval of its ulcerative colitis drug, Simponi for use in the US.

The 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.

UC is a chronic inflammatory bowel disease marked by inflammation and ulceration of the innermost lining of the colon. As many as 700,000 people in the United States are affected by UC.

"The FDA approval of SIMPONI brings an important, new subcutaneous therapeutic option to adults living with moderate to severe ulcerative colitis, a disease where treatment options have been limited. SIMPONI has demonstrated significant benefits in the treatment of ulcerative colitis, a chronic inflammatory bowel disease, and represents a meaningful addition to the treatment armamentaria for gastroenterologists."

William Sandborn, MD, professor and chief of the Division of Gastroenterology at the University of California, San Diego (UCSD) School of Medicine, director of the UCSD Inflammatory Bowel Disease Center, and lead study investigator.

Simponi has already been approved in the US for the treatment of rheumatoid arthritis.