FDA approves Benlysta autoinjector for children with lupus nephritis

Add-on treatment for kidney-damaging complication can be used at home

Margarida Maia avatar

by Margarida Maia |

Share this article:

Share article via email
A red rubber stamp reads

The U.S. Food and Drug Administration (FDA) has approved Benlysta (belimumab) in an autoinjector that can be used at home as an add-on treatment for children ages 5 and older with active lupus nephritis, a serious complication of lupus that causes inflammation and damage to the kidneys.

This approval expands the indication for this formulation of GSK’s Benlysta, which has been available since last year as an at-home autoinjector for subcutaneous, or under-the-skin, use in children ages 5 and older with active systemic lupus erythematosus (SLE) — the most common form of lupus — who are already receiving standard treatment.

“For children and parents of children with lupus nephritis, this approval represents a choice in their care,” Court Horncastle, GSK’s senior vice president and head of U.S. specialty, said in a company press release. “Providing this at-home treatment option with the efficacy and safety of Benlysta is a testament to our ongoing commitment to the lupus community.”

The company noted that “with this approval, pediatric patients … with active lupus nephritis will have a first-of-its-kind treatment option for at-home administration.”

Recommended Reading
Benlysta, lupus nephritis

Benlysta Add-on Therapy Improves Kidney Function in People with Lupus Nephritis, Phase 3 Trial Shows

Lupus occurs when the immune system produces antibodies that mistakenly attack healthy tissues, leading to a wide variety of symptoms. Although rare, lupus can begin in childhood. When it does, it is more likely to cause complications. As many as half of children with lupus develop lupus nephritis within two years of their diagnosis, data has shown.

“In children, lupus tends to be more aggressive and severe than it is in adults,” said Louise Vetter, president and CEO of Lupus Foundation of America. Vetter noted also that “the symptoms can be more intense, and the disease can have long-term effects on a child’s growth and quality of life.”

FDA decision expands indication for Benlysta autoinjector use in children

Benlysta works by blocking BLyS, a protein that plays a key role in B-cell survival and development. B-cells are immune cells responsible for producing antibodies, including the self-reactive ones that cause lupus. Blocking BLyS shortens the lifespan of B-cells and reduces their differentiation into antibody-producing plasma cells, helping to ease disease symptoms.

Before this approval, children with active lupus nephritis could only receive Benlysta through an hour-long intravenous, or into-the-vein, infusion in a clinical setting. That mode of administration could prove burdensome for both patients and their caregivers.

“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,” Vetter said.

Moving forward, caregivers of children using intravenous Benlysta for active lupus nephritis will be able to ask doctors about switching to at-home treatment. The Benylsta autoinjector is designed for use under the skin of the abdomen or thigh. For children younger than 10, the medication should be administered by a healthcare professional or a trained caregiver.

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.

The autoinjector contains 200 mg/mL of belimumab. For children with active lupus nephritis who weigh 40 kg (88 pounds) or more, the recommended dose is 400 mg (two injections) once weekly for four doses, followed by 200 mg once weekly. For those weighing 15 kg (33 pounds) to less than 40 kg, the recommended dose is 200 mg once weekly for four doses, followed by 200 mg every two weeks.

Benlysta was first approved by the FDA in 2011 for the treatment of active SLE in adults, and its use was later extended to adults with active lupus nephritis. The intravenous formulation was approved for children with active SLE in 2019 and for those with active lupus nephritis in 2022.