FDA approves Abbott Laboratories' Humira as ulcerative colitis therapy

ABBOTT PARK, Ill.—As the drug and medical-devicecompany Abbott Laboratories prepares to split in two late this year or earlynext, with the pharmaceutical business to be called AbbVie, it got some goodnews from the U.S. Food and Drug Administration (FDA) in the form of Humira(adalimumab) for inducing and sustaining clinical remission in adult patientswith moderately to severely active ulcerative colitis (UC) when certain othermedicines have not worked well enough.

As Abbott notes, this news—combined with itsearlier approval for the drug to treat moderate to severe Crohn's disease—meansHumira is now approved for the treatment of two primary diseases that comprise inflammatorybowel disease.

But what some market-watchers aremore interested in are the dollar amounts. Humira already brings in about $8billion a year to Abbott, and as Morningstar analyst Damien Conover has saidrecently, this additional indication "will help to continue building thefranchise" and might grow to a point where it will give Abbott—or AbbVie, bythat point in time—additional revenues that could near $500 million a year.

"There is significant unmet medical need in thispatient population, which has not seen a new treatment approved in more thanseven years," said Dr. William J. Sandborn, division chief of gastroenterologyat University of California, San Diego, in Abbott's Sept. 28 news release. "ThisFDA approval is good news for patients and health care professionals who areseeking another option to manage the disease."

Humira works by inhibiting tumor necrosisfactor-alpha (TNF-alpha). The UC approval represents the seventh indication forthis drug in the United States, Abbott, notes, and makes Humira the first andonly self-administered biologic treatment approved for use in this disease.Abbott adds that it is not yet known if Humira is effective in people withmoderate to severe UC who have lost response to or could not tolerate anti-TNF medicines.

UC is a chronic disease that is marked byinflammation and ulceration in the lining of the colon or large intestine. Itis estimated that approximately 700,000 people in the United States alone haveUC. On average, people are diagnosed with UC in their mid-30s, though thedisease can occur at any age. Symptoms include abdominal cramping, rectalbleeding, diarrhea, and urgency and frequency to have a bowel movement. Thesymptoms of UC tend to come and go, with periods of remission betweenflare-ups. Treatment may include medication and/or surgery.

"Since the first FDA approval of Humira in late2002, Abbott has continued to investigate the medication in multiple conditionswith the goal of bringing this treatment option to more patients who maybenefit from it," said Dr. John M. Leonard, senior vice president, GlobalPharmaceutical Research and Development, Abbott. "This approval underscoresAbbott's commitment to investing in and advancing our pipeline to benefitpatients with IBD."

Humira is not just a blockbuster drug but Abbott'sbiggest product by far. In addition to the recent UC approval, along with theoriginal rheumatoid arthritis indication in 2002 and Chrohn's diseaseindication in 2007, Humira has been approved for psoriatic arthritis,ankylosing spondylitis, plaque psoriasis and juvenile idiopathic arthritis.