NORTH CHICAGO (dpa-AFX) - The U.S. Food and Drug Administration Friday approved the expanded use of Abbott Laboratories' (ABT) blockbuster rheumatoid arthritis drug Humira for the treatment of adults with ulcerative colitis who failed standard therapies.
Ulcerative colitis is a chronic disease that causes inflammation and ulcers in the inner lining of the large intestine. It is one of two main forms of chronic inflammatory bowel disease and affects about 620,000 Americans. Symptoms of the disease include diarrhea, rectal bleeding, incontinence, fever, and weight loss.
Humira will now compete with Johnson & Johnson's Remicade (JNJ) in treating ulcerative colitis. The FDA approval also places Humira as the first biologic drug that people could inject themselves to treat ulcerative colitis, as Remicade requires a doctor to administer it intravenously.
The FDA approval was along expected lines as a panel last month recommended approval of the drug to treat ulcerative colitis, stating that the benefits of the drug outweighed the risks.
Humira is already approved for six conditions, including rheumatoid arthritis and Crohn's disease, and is also approved for ulcerative colitis in the European Union. In 2011, Abbott recorded Humira sales of about $8.0 billion. Abbott is also studying the drug for other indications including pediatric Crohn's disease.
Humira's safety and effectiveness for ulcerative colitis were established in two clinical studies involving about 1000 patients. Both the trials showed positive results, with improvement in rates of disease remission compared to a placebo.
Results from the studies showed 16.5 percent to 18.5 percent of patients treated with Humira achieved clinical remission compared with 9.2 percent to 9.3 percent of patients receiving placebo.
Common side effects of Humira include infections, reactions at the injection site, headache, and rash.
The FDA clarified that the effectiveness of Humira has not been established in patients with ulcerative colitis who have lost response to or were intolerant to TNF blockers.
Shares of Abbott Laboratories are trading at $68.74, down 0.84%, on a volume of 3.6 million shares.
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© 2012 AFX News
