Experimental Lupus Drug Benlysta Succeeds in Trial

An experimental drug made by Genome Sciences Inc. for treatment of lupus has performed well in a late-stage clinical trial and resulted in significant improvement in symptoms of patients taking the drug compared to placebo pills.

Benlysta would be the first new therapy approved for lupus in more than 40 years. Lupus is a chronic autoimmune disease that causes damage to the skin, joints, and internal organs and affects as many as 1.5 million Americans and five million people worldwide. More than 16,000 new cases of lupus are diagnosed in the United States each year, mostly among women of color and of child-bearing ages between 15 and 44.

In a one-year-long clinical trial of Benlysta involving 867 people, 57.6 percent of patients taking a high dose of the drug experienced significant improvement in their symptoms compared to just 43.6 percent of people in the study given inactive placebo pills. Over 51 percent of patients taking low doses of the drug saw improvement in their conditions, researchers said. The trial was known as BLISS-52.

Symptoms of lupus include achy joints, fever, arthritis, kidney damage, chest pain, and skin rash.

Benlysta works by inhibiting BLyS, a naturally occurring protein in the body that keeps B-cells functioning normally. B-cells produce antibodies that prevent infection, but in patients with lupus, B-cells are stimulated too much and produce too many antibodies that attack the body.

Benlysta is administered once a month by IV infusion.

Potential Blockbuster Drug

Data from another late-stage trial of Benlysta is expected to be released in November. The first trial was conducted in Asia, Eastern Europe, and Latin America, while the second will be based in Europe and North America, official said. Earlier trials of the drug have resulted in disappointing results, so the later trial is highly anticipated.

Human Genome and GlaxoSmithKline, who partner to market Benlysta, said they plan to seek Food and Drug Administration approvals for the drug in early 2010. That could mean Benlysta could be in pharmacies by late 2010 or early 2011, officials said.

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