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FDA Asks for More Humira Studies

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August 25, 2012 — The U.S. Food and Drug Administration (FDA) is doubting whether Humira is beneficial for patients with ulcerative colitis who have already tried other treatments. Abbott is seeking to expand FDA approval of Humira to include ulcerative colitis patients, which affects about 700,000 people in the United States. The FDA staff doubted whether the benefits of Humira outweighed the risks. In clinical trials, Humira was less than 10% more effective than a placebo.

The poor review is likely to weigh heavily on an advisory panel meeting scheduled for August 28, 2012. The panel will vote on whether to recommend Humira for people with ulcerative colitis. Abbott Laboratories may be asked to conduct additional studies regarding the safety and effectiveness of Humira for treating ulcerative colitis.

According to the FDA, “Additional evidence could help support the evaluation of the benefit-risk assessment for a Humira (ulcerative colitis) indication.”

Although Humira is one of the world’s best-selling drugs, with estimated sales of $9 billion in 2012, it has been linked to some severe side effects. The biological product is made of human cells, and belongs to a class of drugs called “tumor necrosis factor-blockers,” which destroys the body’s cancer-fighting cells and lowers the body’s immune response. Humira has been associated with an increased risk of lymphoma and fungal infections. It has also been linked to a severe type of nerve damage called “peripheral neuropathy,” in which a person suffers severe, permanent pain, tingling, or numbness.

Ulcerative colitis is a type of inflammatory bowel disease. Although no one knows exactly what causes ulcerative colitis, stress and certain foods can trigger inflammation — causing diarrhea, abdominal pain and cramping, fever, pain, intestinal bleeding, and other symptoms.

If regulators approve Humira to treat ulcerative colitis, it will be the first type of biological drug that patients will be able to inject in their homes. The only other similar treatment is Remicade, which is only available in the hospital.

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