CCFA article (from Reuters) - Humira approved for Crohn's

[Guest guest]

U.S. clears use of Abbott drug for Crohn's disease

Last Updated: 2007-02-27 15:11:22 -0400 (Reuters Health)

WASHINGTON (Reuters) - Abbott Laboratories Inc. won U.S. approval to promote its

injectable arthritis drug Humira for treating patients with moderate to severe

forms of Crohn's disease, health officials said on Tuesday.

Humira already is sold for treating three types of arthritis. Crohn's is a

chronic inflammatory disease of the intestines that causes diarrhea, cramping

and abdominal pain.

About 1 million Americans have the condition, the Food and Drug Administration

said in a statement.

Dr. Throckmorton, deputy director of FDA's Center for Drug Evaluation

and Research, said Humira " has been shown to reduce signs and symptoms, and to

induce and maintain clinical remission of Crohn's disease " in patients who did

not respond well to conventional therapy or could not tolerate &

's drug Remicade.

Humira comes with a " black-box " warning, the strongest possible, that use has

been associated with serious, sometimes fatal infections including tuberculosis.

Patients should be tested for a latent tuberculosis infection before starting

Humira treatment, the FDA advised.