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J&J Touts Drug As Alternative to Colitis Surgery

Posted on: Tuesday, 17 May 2005, 15:00 CDT

NEW BRUNSWICK - Johnson & Johnson said its drug Remicade eased the symptoms of ulcerative colitis in two studies on patients who had no success with other therapies, suggesting the medication may offer an alternative to surgery.

Almost 70 percent of patients with moderate to severe colitis, or inflammation of the bowels, got relief from Remicade, compared with about a third of those on a placebo, the New Brunswick company said in a statement Monday. The drug, already approved for the bowel disorder Crohn's disease, had worldwide sales of $2.1 billion last year.

Johnson & Johnson said the findings may encourage the Food and Drug Administration to speed up a review of the company's application to sell Remicade for colitis, which afflicts about 500,000 people in the United States. No other drugs are available to treat advanced stages of the condition and some patients resort to surgical removal of the colon to get relief.

"It gives these patients a good likelihood of responding and not needing to go on to an operation," William Sandborn, a professor at Mayo Clinic College of Medicine in Rochester, Minn., and lead investigator in one of the studies, said Friday. "If there's a medical therapy that can avoid surgery, that's a big deal."

Shares of Johnson & Johnson, the maker of thousands of products ranging from Tylenol to artificial hips, rose 54 cents to close at $67.64 in New York Stock Exchange composite trading. They have gained 24 percent in the past year.

Both studies examined 364 patients with active ulcerative colitis who were unresponsive to a standard therapy such as steroids or medications that suppress the immune system.

In separate trials, 69 percent and 65 percent of colitis patients taking the smallest dose of Remicade experienced improvement after two months, compared with 37 percent and 29 percent of those taking a placebo, Johnson & Johnson said.

About a third of patients taking Remicade were in remission at 30 weeks, compared with 16 percent on placebo in one study and 11 percent in the other, the company said.

The results were released Monday at the Digestive Disease Week conference in Chicago. Johnson & Johnson applied in March for FDA approval of Remicade to treat moderate to severe ulcerative colitis.

Remicade also is used to treat rheumatoid arthritis. Some patients develop severe infections from Remicade, and one person in the ulcerative colitis study contracted tuberculosis, said Sandborn, who has received research support from J&J and has served as a consultant to the company.

"The safety profile is consistent with what we've seen with Remicade," Sandborn said. "There are certainly risks with the other therapies and with surgery."

Source: Record, The; Bergen County, N.J.

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