FDA Approves Belimumab Autoinjection for Patients 5 and Older With Active Lupus Nephritis
This approval offers pediatric patients and caregivers the first subcutaneous option that can be administered at home.
The FDA approved belimumab (Benlysta), a 200 mg/mL autoinjection, for subcutaneous injection in patients 5 years of age and older with active lupus nephritis who are receiving standard therapy. Because of the nature of administration, this approval offers pediatric patients and caregivers the first subcutaneous option that can be administered at home.1
This approval offers pediatric patients and caregivers the first subcutaneous option that can be administered at home. | Image Credit: ladimir1804 - stock.adobe.com
“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 Lupus Foundation of America, said in a news release.1 “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."
Lupus nephritis occurs for patients who have systemic lupus erythematosus (SLE). SLE causes the immune system to make autoantibodies, proteins that attack tissues and organs in the body, including the kidneys. Symptoms of lupus nephritis include blood in the urine, foam in the urine, high blood pressure, swelling in the legs, ankles, or feet, and sometimes hands and face, and high levels of creatinine in the blood. There is no cure for lupus nephritis, but treatment can include steroids, cyclosporine, voclosporin, tacrolimus, cyclophosphamide, azathioprine, mycophenolate, rituximab, and belimumab.2
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,” Court Horncastle, senior vice president and head of US Specialty at GSK, said in the news release.1 ”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.”
In 2024, the FDA also approved the formulation and administration of the drug, a B-lymphocyte stimulator-specific inhibiting antibody, for patients 5 years and older who have SLE. Before this approval, pediatric patients 5 and older could only receive the medication through an intravenous formulation administered by a health care provider based on weight. It would be a 1-hour infusion in a hospital or clinic setting every 4 weeks, following an initial loading phase given on days 0, 14, and 28. This approval expanded access to the medication and allowed health care providers to determine if at-home administration is appropriate for the patient.3
The health care provider administers the treatment, or they can provide instructions for the patients’ caregiver so that they can administer the medication at home 1 per week for children weighing 40 kg or more or once every 2 weeks for patients weighing 15 kg to less than 40 kg.3
Further, belimumab was first approved by the FDA for the treatment of active SLE and is the first and only approved biologic for both SLE and lupus nephritis in more than 50 years, according to GSK.3
READ MORE: Autoimmune Diseases Resource Center
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