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The agency approved Benlysta (belimumab) intravenous infusion for treatment of children with systemic lupus erythematosus.
FDA announced on April 26, 2019 that it had approved Benlysta (belimumab) for the treatment of pediatric patients with systemic lupus erythematosus (SLE, also known as lupus). This is the first approved treatment for children with lupus. The drug has been approved for use in adults since 2011. Lupus is a chronic disease that causes inflammation and damage to tissues and organs, according to FDA, and can be more active in pediatric patients, resulting in increased damage and complications.
The application was given Priority Review designation by FDA. “The agency expedited the review and approval of this application because Benlysta IV fulfils an unmet need for therapies, specifically in pediatric patients with SLE. 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 Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press release.
Studies to test the efficacy of Benlysta IV for the treatment of SLE in children were conducted over 52 weeks in 93 pediatric patients with SLE. The studies found that “the drug’s safety and pharmacokinetic profiles in pediatric patients were consistent with those in adults with SLE,” according to FDA.