U.S. clears use of Abbott drug for Crohn's disease
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. Douglas 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 Johnson & Johnson'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.
Abbott shares fell 17 cents at $54.30 in afternoon trading on the New York Stock Exchange.
