ABBOTT'S HUMIRA APPROVED FOR TREATING CROHN'S DISEASE

The FDA has approved Abbott Laboratories' Humira to treat adult patients with moderately to severely active Crohn's disease, a chronic inflammatory disease of the intestines. Humira is a human-derived, genetically engineered monoclonal antibody. The product acts to reduce excessive levels of human tumor necrosis factor alpha, which plays an important role in abnormal inflammatory and immune responses, according to the FDA.

Humira (adalimumab) has been shown to maintain clinical remission of Crohn's disease in patients who have had an inadequate response to conventional therapy, and in patients who did not benefit from, or who were intolerant to, treatment with Remicade (infliximab).

The drug has been studied in 1,478 patients with Crohn's disease in four clinical trials comparing the drug with a placebo and in two longer-term extension studies.

Humira was previously approved for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.