FDA Approves Belimumab Autoinjector for Pediatric Systemic Lupus Erythematosus

200-mg subcutaneous injection is for children 5 years and older
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WEDNESDAY, May 22, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has approved a 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 <40 kg.

In adult trials, the most common serious adverse reactions were serious infections, some of which were fatal. The most common adverse reactions (≥5 percent) were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection-site reactions. In clinical trials with SLE pediatric patients (aged 5 years and older) and adult patients with lupus nephritis, reported adverse reactions were consistent with those observed in adult SLE trials. 

"Lupus tends to be more aggressive and affect children more severely than adults, with those diagnosed in childhood having higher rates of organ damage," Mary T. Crimmings, interim CEO at the Lupus Foundation of America, said in a statement. "Going to the doctor’s office once every four weeks can be a logistical hurdle for some children and their caregivers, so having the option to administer Benlysta in the comfort of their home provides much-needed flexibility."

Approval of Benlysta was granted to GlaxoSmithKline.

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