FDA Approves Benlysta Autoinjector for Pediatric Patients With Active Lupus Nephritis

MONDAY, June 30, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved an autoinjector of Benlysta (belimumab) for subcutaneous injection in patients ≥5 years of age with active lupus nephritis who are receiving standard therapy.

Benlysta (200 mg/mL), a B-lymphocyte stimulator-specific inhibiting monoclonal antibody, is the first and only approved biologic for both systemic lupus erythematosus and lupus nephritis. It is not recommended in patients with severe active central nervous system lupus.

The most common major adverse reactions seen with Benlysta were serious infections, some of which were fatal. The most common adverse reactions (≥5 percent) were nausea, diarrhea, fever, inflammation of the nasal passages and throat, bronchitis, insomnia, pain in extremity, depression, migraine, and injection site reactions.

“In children, lupus tends to be more aggressive and severe than it is in adults. The symptoms can be more intense, and the disease can have long-term effects on a child”s growth and quality of life,” Louise Vetter, president and CEO of the Lupus Foundation of America, said in a statement. “Having the Benlysta autoinjector provides a much-needed option that can help reduce the burden of frequent clinic visits for treatment and add greater flexibility for children and their families when considering continuity of care and routines of daily life.”

Approval of Benlysta was granted to GSK.

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