FDA Asks for More Humira Studies

August 25, 2012 — A review panel at the U.S. Food and Drug Administration (FDA) is questioning whether the benefits of Humira outweigh the risks for people who have ulcerative colitis who have already tried other treatments. Abbott Laboratories, the company that manufactures Humira, is seeking approval of Humira for ulcerative colitis, in addition to the five other diseases Humira is already approved to treat. The FDA reviewers were concerned that Humira was less than 10% more effective than a placebo, and yet carries a risk of cancer, nerve damage, infection, and other severe side effects.

The questionable review comes just before another FDA panel meets to vote on whether to approve Humira for ulcerative colitis. That meeting is scheduled for August 28, 2012. It is possible that the FDA will ask Abbott to conduct additional safety studies. The company is already testing Humira on patients who have Crohn’s disease, another type of inflammatory bowel disorder.

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

Although Abbott’s two trials met the goals of the study, FDA staff questioned the “clinical meaningfulness” of the studies. The FDA also found that the study designs were limited in a way that “introduced uncertainty” into the results.

Humira is a blockbuster drug for Abbott, and one of the most lucrative pharmaceutical drugs in the world, with projected revenues of $9 billion for 2012. It is the first injectable “biological” drug made of human cells, and it is used to fight a variety of auto-immune disorders. It belongs to the “tumor necrosis factor-blocker” class of drugs, which lowers the body’s immune system response and destroys tumor-fighting cells. Severe side effects include cancer, tuberculosis, lymphoma, permanent nerve damage that causes chronic pain, opportunistic fungal infections, and more.

Approximately 700,000 people in the United States suffer from ulcerative colitis, a type of inflammatory bowel disease. People with ulcerative colitis suffer painful, debilitating inflammation of the intestines, which causes sudden diarrhea, incontinence, abdominal pain, cramping, fever, gastrointestinal bleeding, and other severe side effects.