PHILADELPHIA, PA — The U.S. Food and Drug Administration (FDA) this week approved GSK‘s 200 mg/mL autoinjector of Benlysta (belimumab) for use in children aged five and older who are managing active lupus nephritis (LN). This announcement makes the Benlysta autoinjector the first subcutaneous treatment option available for pediatric patients with LN, a serious complication of lupus.
Lupus nephritis occurs when the immune system attacks the kidneys, leading to inflammation and potential organ damage. It affects 30-50% of pediatric lupus patients, typically within the first two years of diagnosis. The approval of the Benlysta autoinjector provides an at-home treatment option, reducing the need for frequent clinic visits and improving flexibility for patients and their families.
Louise Vetter, President and CEO of the Lupus Foundation of America, highlighted the importance of this milestone. “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. 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.”
GSK’s Court Horncastle, Senior Vice President and Head of U.S. Specialty, underscored the company’s commitment to addressing unmet needs in the lupus community. “For children and parents of children with lupus nephritis, this approval represents a choice in their care. Providing this at-home treatment option with the efficacy and safety of Benlysta is a testament to our ongoing commitment to the lupus community. GSK is driven by the belief that our therapeutic solutions should always prioritize improving patients’ well-being and easing their treatment journey, including for younger patients.”
The Benlysta autoinjector was previously approved for pediatric systemic lupus erythematosus (SLE) in 2024 and is available for caregivers of children currently using intravenous treatments who want to transition to at-home administration. Healthcare providers can train caregivers to administer the autoinjector safely and effectively.
With the Benlysta autoinjector, GSK offers a convenient and innovative solution for children living with lupus nephritis, aiming to improve treatment adherence and overall quality of life for both patients and their families. The product is available for pediatric use immediately.
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