FDA approves belimumab autoinjector for pediatric systemic lupus erythematosus

FDA approves belimumab autoinjector for pediatric systemic lupus erythematosus

FDA approves belimumab autoinjector for pediatric systemic lupus erythematosus

The U.S. Food and Drug Administration has approved GlaxoSmithKline’s 200-mg subcutaneous route of administration of Benlysta (belimumab) for patients 5 years of age and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy.

The B-lymphocyte stimulator-specific inhibiting monoclonal antibody was previously approved for children aged 5 years and older via intravenous administration by health care professionals.

With this approval, a child’s health care provider can determine if at-home administration is appropriate, and if so, the patient’s caregiver can administer the medicine at home via an autoinjector once per week for children who weigh ≥40 kg or once every two weeks for children who weigh 15 kg to
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