Abbott’s Humira Backed by FDA Advisory Panel for Colitis

The benefits of using Abbott Laboratories’ rheumatoid arthritis drug Humira for patients with a type of ulcerative colitis outweigh the risks, a U.S. advisory panel said.

Advisers to the Food and Drug Administration voted 15-2 today in support of Humira’s use in those with moderate to severe ulcerative colitis who don’t respond to conventional therapies. They also voted that the Abbott Park, Illinois-based company doesn’t need to conduct more drug studies in advance of approval. The FDA isn’t required to follow the recommendations.

Abbott is seeking to expand the use of Humira, the company’s top-selling product, in six illnesses, including ulcerative colitis and pediatric Crohn’s disease. Together, the new indications would contribute about $1 billion in sales, said Elizabeth Hoff, a company spokeswoman. Abbott still must find the best dose for colitis patients, panel members said.

“There is a need and desire to explore higher doses, and understand the need and potential for this drug,” said Ivan Fuss, a scientist with the National Institutes of Health in Bethesda, Maryland. “It’s almost like a learner’s permit for a driver’s license. There’s more experience needed.”

Ulcerative colitis causes inflammation and ulceration in the lining of the colon or large intestine and affects 700,000 people in the U.S., according to Abbott. The symptoms include frequent diarrhea, abdominal pain and rectal bleeding. Conventional medications include corticosteroids and immunosuppressants.

Abbott shares rose less than 1 percent to $65.73 at the close in New York. The company has gained 17 percent this year.

Staff Questions

FDA staff has been skeptical about Humira’s benefits for colitis patients. While two trials of the drug for moderate to severe ulcerative colitis met the studies’ goals, FDA staff in an Aug. 24 report questioned the “clinical meaningfulness” of a difference between patients’ reaction to the medicine and a placebo. The staff also said limitations to the studies “introduced uncertainty” to the results.

The panel also voted, 14-3, in agreement with the FDA’s assessment that Abbott hasn’t found the right dosage for the drug in ulcerative colitis.

Humira was approved for treatment of rheumatoid arthritis in 2002. It generated about $8 billion in sales last year for Abbott and competes with Johnson & Johnson’s Remicade, which is cleared to treat rheumatoid arthritis and ulcerative colitis. Pfizer Inc. is studying its experimental rheumatoid arthritis pill tofacitinib in the bowel disease as well.

Easier Use

Unlike Remicade, which requires a doctor to administer the medicine intravenously, Humira can be self-injected, John Medich, head of clinical development for immunology at Abbott, said in a telephone interview.

The risks with Humira are similar to those of Remicade, which are both TNF-antagonists and carry a boxed warning for serious infections such as tuberculosis and for malignancies.

Of the 248 ulcerative colitis patients treated with Humira in an Abbott study, 17 percent achieved clinical remission compared with 8.5 percent who took a placebo after a year, the company said in a May 2011 statement. Clinical remission is measured on a scale that evaluates stool frequency, rectal bleeding and ulcers sighted during endoscopy.

FDA staff last week acknowledged the benefit of convenience with Humira over Remicade, while questioning whether “moving patients from an effective treatment to potentially less effective treatment, while still exposing them to the comparable serious safety risks, is a concern.”

The FDA is scheduled to decide whether to approve the drug by the end of September, according to documents filed with the agency.

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