Abbott’s Humira receives FDA approval for expanded use

Abbott's Humira has been approved for the treatment of moderate to severe ulcerative colitis when certain other medicines have not worked well enough.

Ulcerative colitis is a form of inflammatory bowel disease (IBD). Humira is the first and only self-administered biologic treatment approved for use in this disease.

It’s estimated that approximately 700,000 people in the United States have ulcerative colitis. On average, people are diagnosed during their mid-30s, although the disease can occur at any age.

"There is significant unmet medical need in this patient population, which has not seen a new treatment approved in more than seven years. This FDA approval is good news for patients and health care professionals who are seeking another option to manage the disease."

William J. Sandborn, M.D., division chief, Gastroenterology, University of California, San Diego.

Humira is now able to treat the two primary diseases that comprise IBD, as it is also approved to treat moderate to severe Crohn’s disease.

Humira was first approved by the FDA in 2002 for treatment on adult patients with moderate to severe active rheumatoid arthritis, who have had an insufficient or inadequate response to one or more disease-modifying anti-rheumatic drugs. The drug is Abbott’s biggest product by far, with annual sales of around $8 billion and still growing.