Human Genome Sciences Benlysta Drug Approval for Lupus Patients

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New Break through in Human Genome Sciences Benlysta drug approval for lupus patients. SMF will cover the pros and the cons of the HGSI new drug and benefits to humanity. We will take a look at one of the most positive developments in "biotechnology" in the past 50 years. We have highlighted HGSI and the longer term trends relative to the current drug developments. BENLYSTA is an investigational human monoclonal antibody drug. It is the first in a new class of drugs called BLyS-specific inhibitors that recognize and inhibit the biological activity of B-lymphocyte stimulator, or BLyS, which was discovered by HGS in 1996. We and GlaxoSmithKline (GSK) are developing BENLYSTA under a co-development and commercialization agreement entered into in 2006. In lupus, rheumatoid arthritis and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own healthy tissues.
BENLYSTA has successfully met its primary endpoint in two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE). In June 2010, HGS and GSK submitted regulatory applications seeking approval to market BENLYSTA in the United States and Europe. The FDA has granted BENLYSTA a priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010 – so it is possible that BENLYSTA could receive regulatory approval in the United States before the end of 2010.