J&J Wins Expanded Approval of Simponi for Bowel Disease

Johnson & Johnson (JNJ) won U.S. approval to use its rheumatoid arthritis drug Simponi to treat patients suffering from a moderate to severe inflammatory bowel disease.

The Food and Drug Administration today cleared the drug’s use in adults with a chronic condition called ulcerative colitis after conventional therapy has failed or continuous steroid use is required. About 620,000 people in the U.S. have the disease, which causes ulcers in the colon and rectum that lead to abdominal pain and diarrhea, the FDA said in a statement.

Simponi, first approved in 2009, generated $607 million in sales last year, a figure that may double to $1.2 billion by 2016, according to the average of four analysts’ estimates compiled by Bloomberg. The FDA approved Abbott Laboratories (ABT)’ best-selling arthritis treatment Humira on Sept. 28 for ulcerative colitis, a disease that may lead to removal of the colon.

“It is critical that patients suffering from the serious and painful symptoms of ulcerative colitis have additional treatment options since patients experience the effects of the disease and respond to treatments differently,” Andrew Mulberg, deputy director of FDA’s division of gastroenterology, said in the statement.

Colitis Market

J&J’s $6 billion drug Remicade, the New Brunswick, New Jersey-based company’s top seller, is cleared for ulcerative colitis and Pfizer Inc. (PFE) is studying its Xeljanz in the disease. Patients who participated in a trial of Simponi for the bowel disease had first failed to respond to steroids or medications that suppress the immune system.

As many as 40 percent of people with ulcerative colitis need surgery to remove the rectum and part or all of the colon, according to the National Institutes of Health. Simponi, Remicade and Humira are antibodies that inhibit TNF-alpha, a protein that when overproduced in the body causes inflammation.

The ulcerative colitis market is expected to double to $3.7 billion in 2021 in the U.S., Canada, Japan and top European countries, according to a December estimate from Burlington, Massachusetts-based research and consulting firm Decision Resources.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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