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US clears use of Abbott drug for Crohn's disease
27 Feb 2007 23:15:42 GMT
Source: Reuters
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(Adds company comments, details, closing stock price paragraphs 1-2, 6-7)

WASHINGTON, Feb 27 (Reuters) - Abbott Laboratories Inc. <ABT.N> won U.S. approval on Tuesday to promote its injectable arthritis drug Humira for treating adults with moderate to severe forms of Crohn's disease.

The blockbuster drug 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 <JNJ.N> drug Remicade.

Humira comes with a "black-box" warning, the strongest possible, advising 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.

Approval of Humira for Crohn's disease in the European Union is expected in the first half of 2007, a company statement said. Abbott has previously forecast global Humira sales of more than $2.7 billion in 2007. The drug's generic name is adalimumab.

Abbott shares fell 63 cents, or 1.2 percent, to close at $53.84 on the New York Stock Exchange amid a broad decline of U.S. stocks that saw the Amex Pharmaceutical Index <.DRG> fall 2.5 percent.


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Last updated:Tue Feb 27 23:15:25 2007