Wednesday, November 17, 2010

FDA panel recommends first lupus drug in 50 years

An advisory panel for the US Food and Drug Administration recommended a new drug treatment Tuesday for lupus that if approved would be the first for the disease in over 50 years.

An FDA spokeswoman said the committee voted 13-2 in favor of Benlysta, an experimental drug therapy developed by pharmaceutical companies Human Genome Sciences and GlaxoSmithKline.

The full FDA must next consider whether to approve the drug for the market, likely in December. Typically, the agency follows the advisory panel's recommendations.

"It is possible that BENLYSTA could receive regulatory approval in the United States before the end of 2010," Human Genome Sciences said on its website, noting that the FDA was scheduled to take up the matter on December 9.

There have been no new treatments in the last several decades for lupus, a disease in which the body's immune system attacks its own organs and tissues and is most often seen in women of child-bearing age.

Symptoms can include fever, swollen joints, skin rashes and severe damage of the kidneys, lungs or central nervous system.

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