First lupus drug in 50 years gets nod

Associated Press / November 17, 2010

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ADELPHI, Md. — Federal health specialists say an experimental drug from Human Genome Sciences appears effective for treating lupus, a difficult-to-treat disease for which there has not been a new drug in 50 years.

The Food and Drug Administration’s panel of specialists voted 10 to 5 that the drug Benlysta substantially relieves pain and flare-ups caused by lupus.

The recommendation, which the FDA is not required to follow, brings the drug one step closer to market. Panelists who voted against the drug pointed out that it did not work in certain patient groups.

Lupus is a potentially fatal ailment in which the body attacks its own tissue and organs. Ninety percent of lupus patients are women. The disease causes skin rashes, joint pain, and inflammation of the kidneys and other organs.