Lupus drug Benlysta is two-for-two this week.
GlaxoSmithKline (NYSE:GSK) and drug partner Human Genome Sciences (NASDAQ:HGSI) said Thursday that the European Commission has granted marketing authorization for Benlysta, an announcement that comes just days after Canada’s regulators approved the drug.
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“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,” Dr. Tony Hoos, GSK senior vice president, European Medical Affairs, said in a prepared statement.
Benlysta, the first new lupus treatment in nearly 50 years, was approved by the U.S. Food and Drug Administration in March. London-based GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina, has partnered with Maryland-based Human Genome Sciences on Benlysta’s development since 2006. Benlysta’s regulatory approval in North America and Europe could smooth the path for approvals of the drug in additional markets worldwide. Benlysta is expected to become a new blockbuster drug.
Lupus is an autoimmune disorder that is characterized by pain and inflammation throughout the body as the disease causes the body to attack its own tissues. The Lupus Foundation of America estimates that 5 million people worldwide live with some form of the disease.
GSK did not say when the drug would become commercially available in the European market, but both GSK and Human Genome Sciences began ramping up their European sales teams shortly after the drug’s U.S. approval in anticipation of a European decision on the drug in the third quarter.
