GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the European Commission (EC) has granted marketing authorization for BENLYSTA® (belimumab) 10mg/kg as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus (SLE), with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy.
"The European approval of BENLYSTA represents a significant milestone, and we are very pleased to be able to provide physicians an additional therapeutic option for treating appropriate patients with this chronic disease," said Dr. Tony Hoos, Senior VP, European Medical Affairs, GSK.
"We and GSK are committed to making BENLYSTA available in countries worldwide," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "We are particularly honored to be bringing this medicine forward in Europe, where a number of key academic research institutions were very important to its clinical development."
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