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Benlysta Lupus Drug From Glaxo And HGS Gets European Approval

LONDON -(Dow Jones)- GlaxoSmithKline PLC (GSK, GSK.LN) and U.S.-based partner Human Genome Sciences Inc. (HGSI) Thursday said their lupus drug Benlysta has won European marketing approval. Benlysta, the first new lupus treatment in 50 years, won U.S. approval in March and will be co-marketed by Human Genome Sciences Inc. of Rockville, Md. and Glaxo, Britain's biggest drug maker. Its approval in Europe was expected after experts at the region's regulator backed the medicine in May. Lupus is a chronic autoimmune disorder, with symptoms ranging widely in type and severity. An estimated 5 million people worldwide have the disease. "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," Tony Hoos, senior vice president of European medical affairs at Glaxo, said in a statement. Benlysta, also known as belimumab, is a milestone in the effort to mine data from the human genome to discover and develop new medicines. Analysts expect billions of dollars in sales for the drug. "We and GSK are committed to making Benlysta available in countries worldwide," Thomas Watkins, president and chief executive officer of Human Genome Sciences said, adding: "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." -By Sten Stovall, Dow Jones Newswires; +44 207 842 9292; [email protected]

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