FDA approves Benlysta autoinjector for at-home use in children with lupus
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Key takeaways:
- The FDA approved a 200 mg Benlysta autoinjector for children aged 5 years and older with SLE.
- The approval enables at-home use of a drug previously available to children only through IV.
The FDA has approved a Benlysta autoinjector for children aged 5 years and older with systemic lupus erythematosus, enabling at-home administration for the first time, according to a press release from the manufacturer.
Benlysta (belimumab, GlaxoSmithKline) had previously been available to children only through IV infusion in a hospital or clinic. The newly approved 200 mg injection will now be available for patients aged 5 years and older with active SLE who are receiving standard therapy, if deemed appropriate by a health care provider.
“Patients are our top priority, and we are always working to innovate solutions that can improve lives and address unmet needs,” Court Horncastle, senior vice president and head of U.S. specialty at GlaxoSmithKline, said in the release. “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.”
The injection can be administered once weekly in children weighing at least 40 kg and every 2 weeks in those weighing between 15 kg and 40 kg, according to the company.
“Going to the doctor’s office once every 4 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,” Mary T. Cummings, interim CEO and senior vice president for marketing and communications at the Lupus Foundation of America, said in the release.
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