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The New Drug Application is based on results from two Phase III studies (Northeast Asia and BLISS-SC) and is seeking MHLW approval for belimumab in two formulations; administration via intravenous infusion and subcutaneous injection. The pivotal study of patients with SLE in Northeast Asia (Japan, China and South Korea) evaluated the efficacy and safety of 10mg/kg belimumab administered intravenously every four weeks, plus standard of care (SoC) relative to placebo plus SoC. BLISS-SC evaluated belimumab 200mg administered weekly via subcutaneous injection plus SoC compared to placebo plus SoC.
David Roth, Project Lead for belimumab at GSK said: “Lupus is a chronic and incurable inflammatory disease, which can affect almost any organ in the body. Current treatment options for lupus in Japan are very limited and there is no biologic medicine available that reduces active disease, so this regulatory submission for belimumab is very important progress. If approved, belimumab could address a great unmet medical need for lupus patients in Japan.”
Belimumab intravenous injection 10mg/kg is currently licensed for use in the US, EU and around 50 additional countries worldwide, with the approved trade name Benlysta.
The subcutaneous formulation of belimumab is not currently approved for use anywhere in the world. Regulatory submissions in the US and EU were announced on 23 September 2016.
Benlysta is a trademark of the GlaxoSmithKline group of companies.
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.
Gsk seeks japanese approval, belimumab, treat systemic lupus erythematosus
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