Feb 28 2007
The Food and Drug Administration (FDA) in the United States has given it's approval for the use of the drug Humira (adalimumab) to treat adults suffering from Crohn's disease.
Crohn's disease is a chronic, episodic, inflammatory condition of the gastrointestinal tract and is widely believed to be an autoimmune disease.
It causes inflammation of the bowel and can affect any part of the gastrointestinal tract from the mouth to the anus.
Symptoms of Crohn's disease usually include abdominal pain and diarrhea, which may be bloody, and can cause weight loss.
Skin rashes, arthritis, and inflammation of the eye can also occur.
Crohn's disease affects affects an estimated 1 million Americans and as a rule affects those between 15 and 30 years of age, with no difference between men and women; it is a chronic condition that cannot be cured.
Humira is a human-derived, genetically engineered monoclonal antibody that works by reducing excessive levels of human tumor necrosis factor alpha, which plays an important role in abnormal inflammatory and immune responses.
The drug is already used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, a systemic rheumatic disease that affects the spine and sacroiliac joints.
The deputy director of the FDA's Center for Drug Evaluation and Research, Dr. Douglas Throckmorton, says Humira has been shown in clinical trials involving 1,478 patients, to reduce the signs and symptoms of Crohn's disease.
It also induced and maintained a clinical remission of Crohn's disease in patients who did not respond well to conventional therapy or were unable to tolerate the drug Remicade (Johnson & Johnson).
Humira carries a "black-box" warning, the strongest type of FDA label warning, indicating that it's use has been associated with serious, sometimes fatal, infections, including cases of tuberculosis, opportunistic infections, and sepsis.
According to the FDA patients need to be evaluated for TB risk factors and tested for latent tuberculosis infection before starting Humira treatment.
Humira is manufactured by Abbott Laboratories.