FDA Approves At-Home Belimumab Injection for Children with Lupus Nephritis

The FDA has approved a 200 mg/mL autoinjector of belimumab (Benlysta) for at-home subcutaneous use in children aged 5 years and older with active lupus nephritis receiving standard therapy-marking the first treatment of its kind for pediatric patients.

Lupus nephritis is one of the most serious complications of lupus and occurs when the immune system mistakenly attacks the kidneys, leading to inflammation and possibly to organ damage. About 30-50% of children with lupus develop LN, typically within one to two years after their initial lupus diagnosis.1,2

Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America said: “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.1,2 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."

Court Horncastle, Senior Vice President, and Head of US Specialty, GSK said: “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.”

Caregivers of children who are currently using intravenous infusions of belimumab to manage their LN can work with their child’s healthcare provider to decide if at-home administration via autoinjector is appropriate. If so, the healthcare provider will administer treatment or the healthcare provider will provide instructions to the patients’ caregiver that will allow them to administer the medicine at home via an autoinjector. The 200 mg/mL autoinjector of belimumab will be available for pediatric patients and their caregivers immediately.

About systemic lupus erythematosus (SLE) and lupus nephritis (LN)

Systemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. LN is a complication of SLE and occurs when the immune system mistakenly attacks the kidneys and leads to inflammation and potential organ damage. This inflammation can harm the kidney’s ability to remove waste from the blood.1

LN can lead to end-stage kidney disease, which requires kidney dialysis or a transplant. Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis for people living with lupus.3,4 Manifestations of LN include proteinuria, elevations in serum creatinine and the presence of red and white blood cells in the urine.

About Benlysta

Benlysta (belimumab) is a B-lymphocyte stimulator (BLyS) specific inhibitor that binds to soluble BLyS. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Benlysta does not bind B cells directly. The US FDA first approved Benlysta for the treatment of active SLE; it is the first and only approved biologic for both SLE and LN in more than 50 years, including for the pediatric population.