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First new lupus drug in 100 years

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A new treatment for SLE has been approved in the US, after a 56-year lull in new therapies for the autoimmune disease.

The FDA last week approved belimumab (Benlysta) for patients with lupus who are already receiving standard treatment for the disease (see our previous report here). While there are no known cures for lupus, belimumab is the first new treatment to hit the market in more than half a century.

In one phase-three trial of almost 900 patients, belimumab significantly improved lupus symptoms, with similar adverse-event rates compared with placebo.

Belimumab treatment also reduced the severity of lupus flares in some patients, and others reduced their steroid doses.

The drug’s manufacturer, GSK, has requested European approval and is seeking authorisation in Australia, Canada, Switzerland and Russia.


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