By Heidi Ledford

On 9 March, Benlysta (belimumab) became the first lupus drug approved by US regulators in over half a century. The event was cause for celebration, not only for Human Genome Sciences, the Rockville, Maryland biotechnology company that originally developed the drug, but also for its many competitors racing to be the next to bring a lupus therapy to market.

Clinical trials in lupus are notoriously difficult because the disease is so variable. For decades, companies have tried to bring a lupus drugs to market only to see their most promising candidates fail. One challenge is that patients frequently take two or three drugs, including steroids and other immunosuppressants, to tame their overactive immune systems, and this can mask the effects of an experimental treatment. Benlysta’s approval, however, has given the community hope that such hurdles can be overcome. “This is the path that will give industry the confidence it needs to move forward with other therapies,” says Margaret Dowd, president of the Lupus Research Institute in New York.

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