GSK files lupus drug for Japanese approval

15 December 2016

UK pharma major GlaxoSmithKline (LSE: GSK) has submitted a regulatory application to the Japanese Ministry of Health, Labor and Welfare (MHLW) for belimumab, in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who have an inadequate response to standard therapy.

Benlysta (belimumab) is licensed in the European Union as an add-on therapy in adult patients with active autoantibody-positive SLE, with a high degree of disease activity (eg, positive anti-dsDNA and low complement), despite standard therapy. It is also approved in the USA around 50 additional countries worldwide. Benlysta generated global sales of £271 million ($344 million) in the first nine months of this year.

Clinical backing

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