The U.S. Food and Drug Administration today approved Benlysta (belimumab) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus – often referred to as simply “lupus” – a serious chronic disease that causes inflammation and damage to various body tissues and organs. This is the first time that the FDA has approved a treatment for pediatric patients with systemic lupus erythematosus. Benlysta has been approved for use in adult patients since 2011.
“The agency expedited the review and approval of this application because Benlysta IV fulfils an unmet need for therapies, specifically in pediatric patients with systemic lupus erythematosus. While there is no cure for lupus, treatment can help our youngest patients control their disease with the hope of Although childhood-onset systemic lupus erythematosus is rare, when diagnosed, it is generally more active in children and adolescents than adult patients, particularly in how it impacts organs such as the kidneys and central nervous system. As a result of the disease starting early in life, pediatric patients with systemic lupus erythematosus are at a higher risk for developing increased organ damage and complications from the disease as well as adverse events from the life-long treatments usually required.
The efficacy of Benlysta IV for the treatment of systemic lupus erythematosus in pediatric patients was studied over 52 weeks in 93 pediatric patients with systemic lupus erythematosus. The proportion of pediatric patients achieving the composite primary endpoint, the systemic lupus erythematosus response index (SRI-4), was higher in pediatric patients receiving Benlysta IV plus standard therapy compared to placebo plus standard therapy. Pediatric patients who received Benlysta IV plus standard therapy also had a lower risk of experiencing a severe flare, as well as longer duration of time until a severe flare (160 days versus 82 days). The drug’s safety and pharmacokinetic profiles in pediatric patients were consistent with those in adults with systemic lupus erythematosus.
Benlysta’s doctor and patient information includes a warning for mortality, serious infections, hypersensitivity and depression, based on data from the clinical studies in adults with systemic lupus erythematosus. The drug should not be administered with live vaccines. The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with Benlysta.
The most common side effects in patients included nausea, diarrhea and fever. Patients also commonly experienced infusion reactions, so healthcare professionals are advised to pre-treat patients with an antihistamine.
The FDA granted this application a Priority Review designation. The FDA granted the approval of Benlysta to GlaxoSmithKline.
Source: News Release
United States Food and Drug Administration
April 26, 2019