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Panel Recommends FDA Approval of Humira for Ulcerative Colitis


August 29, 2012 — A panel of outside experts has recommended that the U.S. Food and Drug Administration (FDA) approve the drug Humira for patients with ulcerative colitis, a type of inflammatory bowel disease. The panel voted 15-2 to recommend this new indication. The panel’s recommendation comes just days after FDA staff recommended against approving Humira for ulcerative colitis, citing concerns that the drug was less than 10% more effective than a placebo, and it is associated with many severe side effects.

Abbott Laboratories, the company that manufactures Humira, said that new approvals could add more than $1 billion in sales. Humira is already one of the most popular drugs in the world, with projected sales of $9 billion for 2012. The drug is already approved to treat six autoimmune diseases, including rheumatoid arthritis and Crohn’s disease.

Ulcerative colitis is a chronic gastrointestinal disease that affects approximately 700,000 Americans. The disease causes diarrhea, rectal bleeding, incontinence, abdominal pain, fever, and other debilitating symptoms. If Humira is approved to treat ulcerative colitis, it would be the first “biologic” drug that patients could inject in their homes. Humira belongs to a class of drugs known as Tumor-Necrosis Factor-alpha (TNF) blockers.

The FDA has already published several safety warnings regarding the serious side effects of Humira. The drug has been linked to an increased risk of many types of cancer, including aggressive forms of lymphoma, melanoma, gastrointestinal cancer, lung cancer, and more. Humira has also been linked to peripheral neuropathy, a severe and chronic type of nerve damage that can be extremely debilitating. Humira may also increase the risk of infection, including tuberculosis and pneumonia, due to the fact that it suppresses the patient’s immune system.

It is possible that the FDA will still ask Abbott to conduct additional studies. Experts from the panel that met a few days ago said, “Additional evidence could help support the evaluation of the benefit-risk assessment for a Humira (ulcerative colitis) indication.” The FDA staff questioned the “clinical meaningfulness” of the studies, and also said that the studies “introduced uncertainty” to the results. They also questioned the value of switching patients from an effective treatment to a potentially less-effective treatment with severe side effects.

However, the outside panel supporting Humira recommended against conducting additional studies. They also recommended exploring Humira at higher doses to better understand the potential of this drug. The panel voted 14-3 that Abbott has not yet found the correct dose of Humira for ulcerative colitis, in agreement with the FDA staff.

The FDA does not always follow recommendations from expert panels, but it usually does. The final decision will be made in by the end of September.

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