GlaxoSmithKline receives EU approval for self-injectable version of Benlysta

GlaxoSmithKline has announced that its new self-injectable version of the lupus therapy Benlysta has been approved in Europe.

The European Commission has approved a new subcutaneous formulation of Benlysta as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite standard therapy.

This new formulation of the therapy is delivered via single-dose prefilled syringe and single-dose prefilled pen presentations, administered as a once-weekly injection. It allows patients to administer their own medicine at home, after initial supervision from their clinical team.

Data from the BLISS-SC phase III study of more than 800 patients showed that patients receiving Benlysta plus standard of care treatment experienced a measurable reduction in disease activity levels.

Vlad Hogenhuis, senior vice-president and head of specialty care at GlaxoSmithKline, said: "With the availability of the intravenous and subcutaneous formulations of Benlysta, we can now offer patients with SLE and their physicians additional choice, enabling either home or hospital administration of the medicine."

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