August 29, 2012 — An expert panel has voted 15-2 to recommend expanded approval of Humira to include ulcerative colitis, a type of inflammatory bowel disease that affects approximately 700,000 people. The recommendation comes just days after staff at the U.S. Food and Drug Administration (FDA) recommended rejecting the new approval due to concerns that Humira was less than 10% more effective than a placebo for controlling ulcerative colitis, but is associated with cancer, nerve damage, infections, and other severe side effects.
The FDA staff and the expert panel also disagreed on whether Abbott Laboratories, the company that manufactures Humira, should conduct additional safety studies. The FDA staff found that although Abbott’s two studies met their stated goals, they questioned the “clinical meaningfulness” of the results and found that the studies were designed in a way that “introduced uncertainty.”
The expert panel said that no additional safety studies were necessary, but Abbott should conduct additional studies to find the ideal dosage of Humira for ulcerative colitis patients. The FDA staff agreed that Abbott still had not found the correct dose.
The FDA usually follows expert panel recommendations, but not always. The decision will be made at the end of September 2012.
Officials at Abbott have estimated that additional approvals for Humira could add $1 billion to sales. Humira is one of the world’s best-selling drugs, and sales in 2012 are projected around $9 billion. The FDA has already approved Humira to treat six autoimmune disorders, such as Crohn’s disease and rheumatoid arthritis. It is the only “biologic” drug that patients can inject at home; the only alternative is Johnson & Johnson’s Remicade, which is only available intravenously in a hospital setting.
Ulcerative colitis is an inflammatory bowel disease characterized by chronic inflammation and ulcers in the person’s gastrointestinal tract. Severe cases can be very painful and debilitating. Symptoms include gastrointestinal pain, diarrhea, fever, abdominal pain, rectal bleeding, incontinence, and more.
Although this disorder is very serious, the side effects of Humira can be far worse. Humira is associated with an increased risk of several types of cancer — including high-grade, aggressive forms of lymphoma, melanoma, breast cancer, and more. Humira may also increase the risk of a severe, chronic type of nerve damage called “peripheral neuropathy.” Because Humira works by depressing the patient’s entire immune system, infections such as tuberculosis and pneumonia may be more likely.