FDA Approves Belimumab Autoinjector for Pediatric Systemic Lupus Erythematosus
The U.S. Food and Drug Administration has approved a 200-mg subcutaneous administration of Benlysta (belimumab) for patients aged 5 years and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy. Previously, the B-lymphocyte stimulator specific inhibiting monoclonal antibody was approved for intravenous administration by healthcare professionals for children aged 5 years and older. With this new approval, a child's healthcare provider can determine if at home administration is suitable. If deemed appropriate, the patient’s caregiver can administer the medication at home using an autoinjector. For children weighing 40 kg or more, the medication is given once per week, and for children weighing between 15 kg and less than 40 kg, it is suggested once every two weeks.