HGS Lupus Drug, Submitted For FDA Approval


On Thursday, Human Genome Sciences filed for the marketing approval of BENLYSTA�® (belimumab) to the US FDA as treatment for systemic lupus erythematosus (SLE).

When approved by the US FDA, Human Genome Sciences’ BENLYSTA�® (belimumab) would be the first new lupus drug in more than 50 years.

An investigational human monoclonal antibody drug, BENLYSTA�® (belimumab) is the first in a new class of drugs called BLyS-specific inhibitors that recognize and inhibit the biological activity of B-lymphocyte stimulator (BLyS). In lupus, rheumatoid arthritis and other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies. Autoantibodies are antibodies that attack and destroy the body’s own healthy tissues as very much the case in lupus.

On the other hand, HGS’ partner – GlaxoSmithKline PLC – filed for the drug’s approval in Europe on Friday.


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