Abbott's Humira Approved for Ulcerative Colitis

Humira, Abbott’s biggest seller, was recently approved by the FDA to treat ulcerative colitis.

Patients with ulcerative colitis who have had an inadequate response to conventional therapy now have a new treatment option: Abbott’s Humira (adalimumab).

This approval marks the seventh indication for the blockbuster Humira. The drug was approved to treat ulcerative colitis after treatment with corticosteroids, azathioprine, and 6-mercaptopurine has failed. The drug was previously approved to treat rheumatoid arthritis (2002), psoriatic arthritis (2005), ankylosing spondylitis (2006), Crohn’s disease (2007), plaque psoriasis (2008), and juvenile idiopathic arthritis (2008).

Results from 2 studies encompassing 908 patients showed that 16.5% to 18.5% of patients treated with Humira achieved clinical remission compared with 9.2% to 9.3% of patients receiving placebo.

According to a Reuters report, the drug’s new indication could add $500 million dollars to Abbott’s revenue. The FDA’s approval makes it the first and only self-administered biologic treatment approved for use in this inflammatory bowel disease.

“There is significant unmet medical need in this patient population, which has not seen a new treatment approved in more than seven years,” said William Sandborn, division chief, gastroenterology, University of California, San Diego, in a press release. “This FDA approval is good news for patients and health care professionals who are seeking another option to manage the disease.”

Full prescribing information is available in this PDF.