FDA Panel Backs Roche’s Rheumatoid Arthritis Drug

Despite safety concerns about how the treatment will affect the liver, a panel of medical experts, on Tuesday, voted 10-1 vote for Swiss manufacturer, Roche Holding AG's rheumatoid arthritis drug, Actemra.

In an 11 member panel, 10 members voted in favor of recommending approval, while one voted against the idea.

Though it is not mandatory for the U.S. Food and Drug Administration, who sponsored the panel, to follow its recommendations, but it invariably does so. FDA’s final decision on whether to approve the drug or not is expected by September 18.

Effective in treating rheumatoid arthritis, or RA, in adults - a progressive joint damaging disease that can lead to disability – Actemra blocks interleukin-6 (IL-6), an immune-system protein the spurs inflammation. A highly painful condition, in severe cases the disorder can destruct other organs including the lungs and skin.

Conversely, other widely used drugs block a protein called tumor necrosis factor (TNF).

Though the drug’s ability to relieve symptoms outweighed the potential risks, members on panel urged regular monitoring of patients' liver function and cholesterol levels, as laboratory tests of the drug showed elevated liver enzymes and increased LDL or "bad" cholesterol in some patients.

"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.