Belimumab First Drug in 50 Years Approved by FDA for Lupus

On Wednesday, the U.S. Food and Drug Administration (FDA) approved Benlysta (belimumab)—the first new lupus drug in 56 years, according to a statement from the agency.

Lupus is a potentially fatal autoimmune disease that attacks various tissues, affecting mainly women. The disease goes after the joints, skin, lungs, kidneys, the brain, and the heart, amongst other areas, the FDA noted.

Between 300,000 and 1.5 million people are estimated to suffer from the disease.

“Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease,” stated Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Benlysta is an injectable drug made by Human Genome Sciences and has been shown to moderately relieve symptoms of the disease. The drug also does not appear to work effectively in African Americans, the FDA noted.

The FDA said that the safety and effectiveness of the medication was established in two clinical studies involving 1,684 people. People treated with the medication had fewer symptoms than those treated with placebo.

Side effects of Benlysta include nausea, diarrhea, and fever, the agency said.