Roche wins U.S. panel support for arthritis drug

By Lisa Richwine

SILVER SPRING, Md. (Reuters) - Roche Holding AG (ROG.VX) won a U.S. panel's backing on Tuesday for a new rheumatoid arthritis drug, a potential blockbuster that could help the Swiss company diversify its business.

By a 10-1 vote, a committee of outside experts urged the U.S. Food and Drug Administration to approve the drug, Actemra, for moderate or severe rheumatoid arthritis, a disease that causes painful joint swelling.

The FDA usually clears drugs that win support from advisory panels. A final decision is expected by Sept. 18.

Actemra works differently from other drugs on the market in that it blocks interleukin-6 (IL-6), an immune-system protein involved in inflammation. Other widely used drugs block a protein called tumor necrosis factor (TNF).

Committee members said Actemra's ability to relieve symptoms 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, clinical epidemiology chief at Boston University School of Medicine.

In Roche studies, laboratory tests showed elevated liver enzymes and increased LDL or "bad" cholesterol in some patients. None of the patients showed harm from those effects, FDA reviewers said.

Felson said he was worried about the higher LDL levels.