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news.Human Genome Sciences (HGS) has submitted a biologics license application (BLA) to the FDA, for Benlysta (belimumab) for reducing disease activity in adult patients with autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standardtherapy.
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Benlysta is being developed by GlaxoSmithKline (GSK) and HGS under a co-development and commercialisation agreement entered into in 2006.
Benlysta is an investigational human monoclonal antibody drug. Both the entities cliaimed that it is the first in a new class of drugs called BLyS-specific inhibitors that recognise and inhibit the biological activity of B-lymphocyte stimulator, or BLyS, which was discovered by HGS in 1997.
Benlysta is used for reducing disease activity in adult patients with autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.
GSK said that Belimumab is not approved or licensed anywhere in the world.