GSK’s Benlysta receives Japanese MHLW approval for systemic lupus erythematosus

GSK’s human monoclonal antibody Benlysta (belimumab) has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to treat adult patients with systemic lupus erythematosus (SLE), a chronic, incurable, autoimmune disease.

Indicated for patients who are inadequate responders to existing therapies, Benlysta is approved for use as an add-on therapy in autoantibody-positive SLE patients.

Benlysta will be available in two formulations, one as an injection for intravenous (IV) treatment and the other as an injection for subcutaneous (SC) use.

The drug is designed to selectively target and directly bind to B-lymphocyte stimulator (BLyS) to help reduce B-cells and decrease the immuno-inflammation observed in patients with the disease.

GSK Specialty Care head, senior vice-president Vlad Hogenhuis said: "Patients living with SLE have limited treatment choices available and may have to endure the associated side effects these can cause.

"SLE symptoms are broad, variable and unpredictable in their intensity, which means an individualised treatment approach is needed.

"Benlysta, in its IV form, has been used to treat thousands of patients worldwide.

"We can now provide an important new treatment option to physicians and SLE patients in Japan."

SLE, which is the most common form of lupus, affects approximately 70% of an estimated five million people with lupus worldwide, with an estimated 60,000 registered patients in Japan.

The approval has been granted based on data from two pivotal Phase III studies, Northeast Asia IV study and the BLISS-SC study. Efficacy and safety data from two global BLISS-IV Phase III studies, BLISS-52 and BLISS-76, has also been used.

While Benlysta IV 10mg/kg is licensed for use in the US, EU, and more than 70 countries across the globe, the drug’s subcutaneous formulation is approved for use in the US and is under review or planned regulatory submissions in other countries.