RespiteMatch.com Health Blog

By Val Brickates Kennedy, MarketWatch
Last Update: 4:37 PM ET Sept. 16, 2005

BOSTON (MarketWatch) - The Food and Drug Administration has approved Johnson & Johnson’s rheumatoid arthritis drug Remicade for the treatment of ulcerative colitis, a debilitating digestive disease.
According to the company Friday, the FDA has approved the drug to treat moderate-to-severe ulcerative colitis in patients who have not responded well to other standard treatments.

J&J (JNJ: news, chart, profile) said Remicade can greatly reduce symptoms of the disease, with some patients even going into remission. The drug also allows patients to stop using corticosteroid drugs, a standard therapy for the disease which can cause serious side effects.

About 500,000 Americans suffer from ulcerative colitis, with 60% of those falling into the moderate-to-severe category. Some severely ill patients end up having their colons surgically removed in order to cope with the disease, according to the company.

Friday’s approval is the fifth for the drug by the FDA. Remicade is also approved to treat rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis and psoriatic arthritis.

The drug, which has been on the market since 1998, was developed by J&J’s biotech unit, Centocor. The company plans to file later this month to have the drug approved to treat psoriasis, according to Centocor.

According to Centocor president Julie McHugh, the new approval should expand Remicade’s market by about 20%. The drug had 2004 sales of $2.1 billion.

McHugh said Remicade, which is generally administered every eight weeks intravenously, costs about $15,000 a year.

Shares of J&J closed up 1.3% at $65.18 on Friday.

Val Brickates Kennedy is a reporter for MarketWatch in Boston.