The European Commission (EC) has approved a new subcutaneous (SC) formulation of GSK’s Benlysta (belimumab) for the treatment of patients with active autoantibody-positive systemic lupus erythematosus (SLE).
Benlysta can be used in Europe as an add-on therapy in adult patients with active autoantibody-positive SLE and a high degree of disease activity despite standard therapy.
SLE is a chronic, incurable, autoimmune disease accompanied with a range of symptoms that can fluctuate over time and affect almost any system in the body, resulting in painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage.
As a BLyS-specific inhibitor, Benlysta is a human monoclonal antibody that binds to soluble BLyS.
GSK specialist care senior vice-president and head Vlad Hogenhuis said: “We are delighted to receive today’s European approval. The impact of living with lupus forces individuals to adapt their daily personal and working lives in order to manage this complex, chronic disease.
“With the availability of the intravenous (IV) and SC formulations of Benlysta, we can now offer patients with SLE, and their physicians, additional choice, enabling either home or hospital administration of the medicine.”
The GSK therapy is currently the only medicine particularly developed and approved for SLE.
It has been approved by the EC as a single-dose prefilled syringe and a single-dose prefilled pen (autoinjector), and can be administered as a once-weekly injection of 200mg.
The two SC presentations allow patients to self-administer the medicine at home, after initial supervision from their clinical team, if considered appropriate.
The current approval is based on the results obtained from the phase III BLISS-SC trial that involved more than 800 patients with active SLE.
The Benlysta IV formulation is already licensed for use in more than 70 countries worldwide, including the US, Japan and European Union (EU) countries.