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Roche wins U.S. panel support for arthritis drug

Tue Jul 29, 2008 2:45pm EDT

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(Adds panel member quote, background)

SILVER SPRING, Md., July 29 (Reuters) - Roche Holding AG's (ROG.VX) drug Actemra should be approved for treating moderate or severe rheumatoid arthritis, a U.S. advisory panel said on Tuesday in a 10-1 vote.

The Food and Drug Administration will make the final decision but usually follows panel recommendations. A ruling is expected by Sept. 18.

Roche bills the drug as a potential blockbuster.

Committee members said Actemra's benefits outweighed potential risks, but some urged tracking of patients' liver function and cholesterol levels.

"The safety concerns are real, and I think there is going to have to be monitoring," said panel member Dr. David Felson, chief of clinical epidemiology at Boston University School of Medicine.

Actemra is sold in Japan by Roche's partner Chugai Pharmaceutical Co Ltd (4519.T) but has yet to reach the market in the United States or Europe.

Rheumatoid arthritis, or RA, is a joint inflammation that causes pain, stiffness, swelling and joint damage. More than 21 million people worldwide, including 2.5 million Americans, are estimated to have the disease, Roche said. (Reporting by Lisa Richwine; Editing by Steve Orlofsky)






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