GSK receives approval for Benlysta in Japan for the treatment of systemic lupus erythematosus

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GSK announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Benlysta (belimumab) for the treatment of adult patients with systemic lupus erythematosus (SLE) who are inadequate responders to existing therapies. Benlysta is for use as an add-on therapy in autoantibody positive SLE patients. SLE is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time, affecting almost any system in the body.

Benlysta is a human monoclonal antibody that works by selectively targeting B-lymphocyte stimulator (BLyS), an important factor in SLE. It binds to BLyS directly, which reduces B-cells and helps decrease the immuno-inflammation observed in SLE patients.

The medicine will be available for patients in two formulations, as an injection, for intravenous (IV) use and an injection, for subcutaneous (SC) use. The IV formulation is administered by healthcare professionals to patients as a weight-based dose of 10mg/kg, via a one-hour infusion in a hospital or clinical setting every four weeks (following an initial loading phase given at Weeks 0, 2 and 4). The subcutaneous formulation can be administered as a once weekly injection of 200mg, from either a single-dose prefilled syringe or from a single-dose autoinjector.

Vlad Hogenhuis, Senior Vice President, Head of Specialty Care, GSK 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 and with today’s approval of two formulations, we are delighted that we can now provide an important new treatment option to physicians and SLE patients in Japan.”

The approval is based on data from two recent pivotal Phase III studies (Northeast Asia IV study and BLISS-SC study) and also efficacy and safety data from two earlier global BLISS-IV Phase III studies (BLISS-52, BLISS-76). The studies measured reduction in disease activity at Week 52 in patients with active SLE receiving belimumab plus standard of care, versus those receiving placebo plus standard of care (assessed by SRI, a composite measure of efficacy in lupus). The pivotal Northeast Asia study (Japan, China and South Korea) evaluated the efficacy and safety of belimumab administered intravenously every four weeks in 705 patients and the BLISS-SC study evaluated subcutaneous belimumab administered weekly in 836 patients. The 2 earlier BLISS-IV global trials evaluated the efficacy and safety of belimumab administered intravenously in a total of 1,684 patients.

Benlysta IV 10 mg/kg is also licensed for use in the US, EU and more than 70 countries worldwide. Benlysta subcutaneous formulation was approved for use in the US in July 2017 and further regulatory submissions are under review or planned in other countries during the course of 2017.

About Benlysta (belimumab)
Benlysta is currently the only medicine specifically developed and approved for SLE. Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. Benlysta does not bind B cells directly. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.

Japanese Drug Information for Benlysta will be available soon at https://www.healthgsk.jp/. Prior to the label being posted online, a copy may be requested from one of the GSK Media or Investor Relations contacts listed in the “GlaxoSmithKline enquiries” section at the end of this document.

About systemic lupus erythematosus (SLE)
Systemic lupus erythematosus (SLE) is the most common form of lupus, affecting approximately 70 percent of an estimated 5 million people with lupus worldwide. There are an estimated 60,000 registered patients living with SLE in Japan. SLE is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage.

Important Safety Information for belimumab
The following Important Safety Information (ISI) is based on a summary of the Japanese Drug Information for Benlysta (belimumab). Please consult the full Drug Information for all the labelled safety information for Benlysta.

Precautions for the Indication
Use BENLYSTA as an add -on therapy in patients with disease activity remaining despite previous treatment with SLE drugs, e.g. steroids, immunosuppressive agents. Use in patients with SLE confirmed to be autoantibody positive.

Efficacy and safety have not been evaluated in SLE patients with severe lupus nephritis or central nervous system lupus.
The efficacy and safety of Benlysta has not been evaluated in combination with other biologic drug or cyclophosphamide intravenous injection.

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