FDA scrutinizes benefit of long-awaited lupus drug

First new treatment for the disease in decades gets a hard look from health officials

By Associated Press
Published November 12, 2010 3:05PM (EST)

Federal health officials say the first new drug developed to treat lupus in decades relieves disease symptoms, but appears less effective in patients from certain racial and ethnic backgrounds.

Human Genome Sciences is asking the Food and Drug Administration to approve Benlysta to relieve symptoms of lupus, a difficult-to-treat ailment in which the body attacks its own tissue and organs. If approved, the drug would be the first new lupus treatment in about 50 years.

However, FDA reviewers are concerned that African American patients appeared to fare worse when taking the drug. Reviewers also note that the drug's benefit appeared greater among patients from Latin America, compared with those from the U.S. and Canada.

An FDA panel will vote on the drug's effectiveness at a public meeting next week.

Associated Press

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