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FDA Approves New Lupus Drug

FDA Approves New Lupus Drug
The Food and Drug Administration approved the first new drug in 56 years to treat lupus.

Systemic lupus is a chronic, debilitating and life-threatening immune system disorder. The painful disease is more common in women than men. It affects the skin, blood, kidneys, heart and lungs.

Now for the first time in five decades there is a new injectable drug to treat it.

It’s called Benlysta (belimumab). The biotech company Humane Genome Sciences (HGS) developed the drug over the past 15 years. HGS said the drug could treat about 200,000 of the estimate 1 million Americans who are thought to have lupus.


Researchers said the drug works by preventing the body from attacking it’s own tissue in some people with lupus.

But, it doesn’t work for everyone. Clinical studies found Benlysta had “no positive effect” in African American women —who are three times more likely than other races to have lupus.

The FDA said they would require the drug’s makers to do an exclusive study in African-Americans.

Still, the drug is expected to be available for patients in about two weeks. The pharmaceutical giant GlaxcoSmithKline (GSK) will help HGS market Benlysta.

In a written statement, Mocef Slaoui, Ph.D., chairman of research and development at GSK said lupus patients have been waiting for years for new ways to manage the chronic disease.


“The approval of Benlysta is an important step for appropriate lupus patients. We look forward to working together with HGS to bring this new medicine to patients in the U.S.”

Scripps Research Institute in La Jolla did early research linked to the drug’s development .