GSK says FDA approves Benlysta Autoinjector for children with SLE

GSK plc announced that the Food and Drug Administration has approved a 200 mg subcutaneous route of administration of Benlysta, a B-lymphocyte stimulator-specific inhibiting monoclonal antibody, for patients five years of age and older with active systemic lupus erythematosus, or SLE, who are receiving standard therapy. “This option provides pediatric patients the possibility to receive the treatment at home. Previously, children aged five years and older could only receive belimumab through an intravenous formulation, administered by healthcare professionals to patients as a weight-based dose of 10 mg/kg, via a one-hour infusion in a hospital or clinic setting every four weeks following an initial loading phase given on days 0, 14 and 28. Now, a child’s healthcare provider will determine if at-home administration is appropriate. If so, the healthcare provider will administer treatment or the healthcare provider will provide instructions to the patients’ caregiver that will allow them to administer the medicine at home via an autoinjector once per week for children who weigh 40 kg or more, or once every two weeks for children who weigh 15 kg to less than 40 kg,” the company stated.