FDA Approves Humira for Moderate to Severe Ulcerative Colitis

The US Food and Drug Administration announced that it has approved Abbott Laboratories’ rheumatoid arthritis drug Humira for treating moderate to severe ulcerative colitis. Humira was initially approved by the FDA for treating rheumatoid arthritis back in 2002 and since then has also been approved for treating psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis and juvenile idiopathic arthritis. The FDA revealed that the drug can now be used to treat ulcerative colitis in adults who have failed to respond to immunosuppressant medicines, including corticosteroids.

“Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual's needs. Today's approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy”, FDA’s Division of Gastroenterology and Inborn Errors Products said.

Humira is Abbott Laboratories’ most successful drug and accounts for annual sales of over $8 billion with analysts predicting that the latest approval by the FDA could generate another $500 million in sales.

Source-Medindia