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FDA Advisers Endorse New Lupus Drug
Date:11/16/2010

By Steven Reinberg
HealthDay Reporter

TUESDAY, Nov. 16 (HealthDay News) -- U.S. Food and Drug Administration advisers voted 13-2 Tuesday to recommend approval of the first new drug in more than 50 years to treat the autoimmune disease lupus.

The drug, belimumab (Benlysta), is a so-called monoclonal antibody drug developed to treat patients who suffer from systemic lupus erythematosus.

Lupus is an autoimmune disease in which the body produces antibodies that attack and destroy healthy tissue. This can damage joints, skin, blood vessels and organs. Benlysta works by inhibiting the production of these antibodies.

While the FDA is not bound by its advisory committees' recommendations, it usually follows them.

Benlysta is made by Human Genome Sciences and GlaxoSmithKline.

In a report submitted to the advisory committee before the vote, the FDA had expressed some concerns about the efficacy and safety of the drug.

But other experts expressed optimism about the drug's worth.

"I really do think the drug is efficacious," said Sandra C. Raymond, president & CEO of the Lupus Foundation of America, who attended the advisory panel meeting. "What I'm hearing in terms of efficacy is pretty strong."

In a statement commenting on the panel's vote, Margaret Dowd, president and CEO of the Lupus Research Institute, said that, "we couldn't be more pleased. It's a historic day for the lupus community."

The FDA said it wanted the advisory panel to look at both the efficacy data, which according to the agency was modest, and the safety data, which the agency believed raised some serious issues. Specifically, the drug has been linked to depression and suicide.

Raymond noted, however, that many patients with lupus suffer from depression. And many patients in clinical trials testing the drug were also taking antidepressants, she added.

The advisory committee actually took three votes Tues
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