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

By Steven Reinberg
HealthDay Reporter

TUESDAY, Nov. 16 (HealthDay News) -- U.S. Food and Drug Administration advisers were weighing Tuesday whether to recommend 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.

In research papers submitted to the advisory committee, the full FDA expressed some concerns about the efficacy and safety of the drug.

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

The FDA said it wants the advisory panel to look at both the efficacy data, which according to the agency is modest, and the safety data, which the agency believes raises some serious issues. Specifically, the drug has been linked to depression and suicide.

Raymond noted 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 is scheduled to vote on whether the drug's risks are mitigated by the benefits it has to offer to patients who are already receiving standard care.

The agency said it is basing its concerns on the results of two phase 3 trials that compared Benlysta with a placebo.

"The risks associated with belimumab include infection, malignancy, suicidality, and overall number of deaths with a numerical imbalance that favored placebo treatment over belimumab treatment," according to the FDA.

Safety is important, Raymond said, but the drugs used to treat lupus now carry some significant side effects, too. "The safety of some of our medications is not good," she said. "So what are we comparing it to?"

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