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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 Tuesday. The other two votes endorsed the safety and the effectiveness of the drug.

The agency said it based 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 paper filed before the vote.

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?"

The current treatments include chemotherapy and steroids, which can leave the door open to infections, cancers and other unwanted consequences, Raymond said.

Dr. Joan Merrill, head of clinical pharmacology at the Oklahoma Medical Research Foundation and medical director of the Lupus Foundation of America, added that "the safety data on Benlysta looks better than we usually see with biologics."

"We have to keep in mind that there is a natural ceiling on the percentage of patients who can respond to any targeted treatment. We do not yet know exactly how good Benlysta is," Merrill said.

What is known is that Benlysta was shown to be statistically superior to a placebo in two phase 3 trials, she said.

"I hope that the FDA will be able to approve it, after they complete the serious deliberations that they must make on all the data," Merrill said.

Another expert agreed.

"I am hoping the advisory committee will recommend approval of Benlysta, because it has been associated with statistically significant improvement in the response to treatment in two well-designed randomized, prospective, placebo-controlled trials studying different populations of people with systemic lupus," said Dr. Bevra H. Hahn, chief of rheumatology at UCLA's David Geffen School of Medicine.

"Very important are the observations that fatigue [a major complaint of almost everyone with lupus] and physical function improved significantly," she added.

More information

To learn more about lupus, visit the Lupus Foundation of America.

SOURCES: Sandra C. Raymond, president & CEO, Lupus Foundation of America; Joan Merrill, M.D., head, Clinical Pharmacology, Oklahoma Medical Research Foundation, Medical Director, Lupus Foundation of America; Bevra H. Hahn, M.D., professor, medicine, and chief, rheumatology, David Geffen School of Medicine, University of California, Los Angeles; Nov. 16, 2010, statement, Lupus Research Institute


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