A new subcutaneous formulation of GlaxoSmithKline’s Benlysta has been approved as an add-on therapy for certain in adults with the autoimmune disease systemic lupus erythematosus (SLE).
The approval enables home administration of the drug as a once-weekly injection via a single-dose pre-filled syringe or single-dose autoinjector pen for patients with active autoantibody-positive SLE with a high degree of disease activity despite standard therapy.
The subcutaneous form of the Benlysta (belimumab) adds to the existing intravenous (IV) formulation licensed for use in Europe in 2011.
Vlad Hogenhuis, head of Specialty Care at GSK, said the firm is delighted with the 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 IV 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”.