Self-injected Benlysta Approved in Europe to Treat Lupus Patients with Active Disease

The European Commission has approved the new, self-administered and injectable formulation of  Benlysta (belimumab), by GSK, as an add-on therapy for certain adults with systemic lupus erythematosus (SLE).

The approval applies to lupus patients with active autoantibody-positive disease and high disease activity in spite of standard therapy.

Benlysta in a self-administered, injectable formulation was approved for use in the U.S. in July 2017 and in Japan in September 2017. Regulatory submissions are under review or planned in other countries.

The new subcutaneous (SC, an injection just under the skin) presentation comes as a single-dose prefilled syringe or as a single-dose prefilled pen (autoinjector), taken once weekly. This allows patients to take their medicine at home, but only in appropriate cases and once they have been supervised by their treating team.

The existing intravenous (IV) formulation was licensed in Europe in 2011. But the need to receive the intravenous treatment at a hospital or clinic once every two weeks to begin with, and monthly thereafter, can be inconvenient and some may have abandoned the treatment because of it.

Approval stems from the results of the BLISS-SC Phase 3 pivotal study (NCT01484496) in more than 800 lupus patients.

Researchers reported their results in the article, “Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty‐Two–Week Randomized, Double‐Blind, Placebo‐Controlled Study,” published in the journal Arthritis & Rheumatology.

They assessed the reduction in disease activity in patients receiving Benlysta plus standard of care, compared to those receiving placebo plus standard of care.

Response to treatment was 61 percent in the group receiving Benlysta plus standard care, versus 48 percent in those given standard of care alone.

“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 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,” Vlad Hogenhuis, senior vice president, head of Specialty Care, GSK, said in a press release.

Benlysta was developed by Human Genome Sciences, which was acquired by GSK in 2012.