The approval makes belimumab (Benlysta) the first at-home treatment in its class for patients 5 years and older with systemic lupus erythematosus (SLE).
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