On May 20, the U.S. Food and Drug Administration (FDA) approved a 200-mg subcutaneous route of administration for the B-lymphocyte stimulator–specific inhibiting monoclonal antibody belimumab (Benlysta) in pediatric patients aged 5 years and older with systemic lupus erythematosus.

Prior to the approval, this patient population was only able to receive intravenous belimumab as a weighted 1-hour infusion of 10 mg/kg once every 4 weeks in hospital or clinical settings.

With the new indication—announced by the agent’s manufacturer, GSK—pediatric patients can now be evaluated to determine their eligibility for at-home belimumab administration. If deemed appropriate, physicians can provide patients’ caregivers with instructions on how to deliver the drug with an autoinjector once per week in those weighing 40 kg (about 88 pounds) or more, or once every 2 weeks in those weighing 15 to < 40 kg (about 33 to 87 pounds).

“Going to the doctor’s office once every 4 weeks can be a logistical hurdle for some children and their caregivers, so having the option to administer [belimumab] in the comfort of their home provides much-needed flexibility,” noted Mary T. Crimmings, BA, Interim Chief Executive Officer and Senior Vice President for Marketing and Communications at the Lupus Foundation of America.