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MONDAY, April 29, 2019 (HealthDay News) -- The intravenous drug Benlysta (belimumab) has been approved by the U.S. Food and Drug Administration to treat children with lupus, a chronic disease that triggers inflammation and damages tissues and organs throughout the body.
"While there is no cure for lupus, treatment can help our youngest patients control their disease with the hope of improving their quality of life and lowering their risk of long-term organ damage and disability," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
Benlysta was clinically evaluated among 93 children with the disease. Those who received Benlysta plus standard therapy had a lower risk of a severe flare, the agency said.
The drug's label includes warnings for increased risk of death, serious infections, allergic-like reactions and depression. The drug should not be given at the same time as a person gets a live vaccine, the agency warned.
The drug's most common side effects include nausea, diarrhea and fever. Given the medication's history for causing allergic-like reactions, health professionals are advised to pre-treat users with an antihistamine, the FDA said.
Benlysta is produced by GlaxoSmithKline, based in the United Kingdom.
-- Scott Roberts
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