New self-injectable form of belimumab approved for SLE
medwireNews: A new subcutaneous form of belimumab for the treatment of adult patients with systemic lupus erythematosus (SLE) has been approved by the US FDA and recommended for approval by the European Medicines Agency (EMA).
“The new pharmaceutical form allows patients or their carers to administer the medicine themselves,” says the EMA.
Subcutaneous belimumab is given as a 200 mg solution in a prefilled syringe or autoinjector, and will be available alongside the existing 120 mg and 400 mg powder forms that are provided for reconstitution and intravenous injection.
The indication for subcutaneous belimumab remains the same as that for the intravenous form of the drug, and is recommended as an add-on therapy for patients with active, autoantibody-positive SLE who are receiving standard treatment.
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