The Japanese Ministry of Health, Labour and Welfare has approved belimumab (Benlysta, GlaxoSmithKline) for treatment of adults with active, autoantibody-positive systemic lupus erythematosus (SLE) who do not respond adequately to existing therapies, the company has announced.
Belimumab is a B-lymphocyte stimulator protein inhibitor that is thought to decrease the amount of abnormal B cells, believed to be a mechanism of action in SLE.
Belimumab will be available in Japan in intravenous (IV) and subcutaneous (SC) formulations. The IV formulation is administered in a weight-based dose of 10 mg/kg via a 1-hour infusion in a hospital or clinical setting every 4 weeks (following an initial loading phase given at weeks 0, 2, and 4). The SC formulation can be administered as a once-weekly injection of 200 mg, from either a single-dose prefilled syringe or a single-dose autoinjector.
The US Food and Drug Administration (FDA) approved an IV formulation of belimumab in 2011 and an SC formulation earlier this year. Both formulations are also approved in the European Union.
Belimumab is for use as an add-on therapy in patients with SLE who are confirmed to be autoantibody positive and continue to have disease activity despite previous treatment with steroids and immunosuppressive agents, the company says.
The efficacy and safety of belimumab have not been evaluated in patients with SLE who have severe lupus nephritis or central nervous system lupus, nor have efficacy and safety been evaluated in combination with other biologic drug or cyclophosphamide IV injection, the company notes.
Belimumab may increase the risk for infection, and it may reactivate tuberculosis in patients with a history of tuberculosis. Serious, sometimes fatal infections, including sepsis, pneumonia, and fungal infection, have been reported.
Clinicians should carefully monitor patients for possible development or exacerbation of infection and patients should be told to contact their healthcare provider if signs and symptoms of infection surface after belimumab administration, the company advises.
Cases of malignant tumors have been reported, but any causal link with belimumab is unknown.
Belimumab “must not be used in patients unless its potential clinical benefit justifies the potential risks and must be given by doctors with sufficient SLE therapeutic knowledge/experience at medical institutions with relevant emergency units in handling infections,” the company says.
Full Japanese drug information for belimumab will be available online soon, the company says.
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