Benlysta autoinjector OK’d as add-on treatment for SLE children

FDA approval marks 1st time lupus children can get GSK therapy at home

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by Margarida Maia |

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The U.S. Food and Drug Administration (FDA) has approved the use of Benlysta (belimumab) in a prefilled autoinjector as an add-on treatment for children ages 5 and older with systemic lupus erythematosus (SLE), the most common form of lupus.

This is the first time children with active disease who are on standard medications for lupus have the chance to receive Benlysta at home as a subcutaneous, or under-the-skin, injection, according to its developer GSK.

“This approval for an at-home treatment is the first and only of its kind for children with lupus and is a testament to our continued commitment to the lupus community,” Court Horncastle, GSK’s senior vice president, said in a company press release.

Administration of Benlysta via the autoinjector is expected to lessen the treatment burden for these young patients.

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SLE occurs when the immune system produces antibodies that wrongly attack healthy tissues in the body, causing inflammation and damage. While it is rare, the disease can start to manifest early in life during childhood. When this happens, it is more likely to cause complications and require lifelong treatment.

“Lupus tends to be more aggressive and affect children more severely than adults, with those diagnosed in childhood having higher rates of organ damage,” said Mary T. Crimmings, interim CEO and senior vice president for marketing and communications at the Lupus Foundation of America, a nonprofit advocacy group.

Benlysta works by blocking BLyS, a protein that helps B-cells live longer. B-cells are the immune cells responsible for producing antibodies, including those that drive lupus. Blocking BLyS shortens the lifespan of B-cells, thereby easing lupus symptoms.

Prior to this approval, children with active SLE or lupus nephritis, an inflammation of the kidneys that can occur as a complication of lupus, could only receive Benlysta intravenously or via an infusion directly into the bloodstream, which takes about one hour to administer. Treatment is given every four weeks, or about once per month, by a healthcare professional in a clinical setting.

Going to the doctor’s office once every four weeks can be a logistical hurdle for some children and their caregivers, so having the option to administer Benlysta in the comfort of their home provides much-needed flexibility.

The new formulation will become available immediately to caregivers of eligible children. It comes as a single-dose prefilled autoinjector containing 200 mg of Benlysta in a clear to opalescent and colorless to pale yellow solution that can be administered at home.

“Going to the doctor’s office once every four weeks can be a logistical hurdle for some children and their caregivers, so having the option to administer Benlysta in the comfort of their home provides much-needed flexibility,” Crimmings said.

The autoinjection can be administered under the skin in the abdomen or thigh. For children weighing 40 kg (88 pounds) or more, the therapy should be given once weekly. For those weighing between 15 kg (33 pounds) and less than 40 kg, Benlysta should be administered every two weeks.

A healthcare provider will determine if at-home administration is suitable, and will either administer the treatment or instruct caregivers on how to do it. Regardless of who is administering the medication, at-home treatment is expected to provide a more convenient option for children with SLE and their families.

“Patients are our top priority, and we are always working to innovate solutions that can improve lives and address unmet needs,” said Horncastle, who also serves as head of U.S. specialty at GSK.

Benlysta was first approved in 2011 by the FDA to treat adults with active SLE. Later, its approval was extended to cover adults with active lupus nephritis. Its intravenous formulation was approved for children ages 5 and older with active SLE in 2019, and for youth with active lupus nephritis in 2022. The use of the autoinjector for Benlysta administration in adults was approved by the FDA in 2017.