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FDA takes closer look at long-awaited lupus drug

Associated Press / November 13, 2010

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WASHINGTON — Federal health officials said yesterday that the first new drug developed to treat lupus in decades relieves disease symptoms, but they questioned the significance of its benefits, which varied across different patient groups.

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 — which is being codeveloped with GlaxoSmithKline — would be the first new lupus treatment in about 50 years.

Two of three studies submitted by the companies show Benlysta improved patients’ scores on a test that measures lupus symptoms.

However, FDA reviewers raised a number of questions about the strength of Benlysta’s effect in briefing documents posted online yesterday.

Shares of Human Genome Sciences fell $2.88, or 10.9 percent, to close at $23.60 in trading.