Pharma

GSK’s lupus drug Benlysta gets Health Canada approval

Lupus drug Benlysta, developed by GlaxoSmithKline (NYSE:GSK) and drug partner Human Genome Sciences (NASDAQ:HGSI), can now count Canada among the markets where it will offer the first new lupus treatment in nearly 50 years. The companies on Tuesday announced that Health Canada has approved Benlysta. People with lupus in Canada can expect to see the […]

Lupus drug Benlysta, developed by GlaxoSmithKline (NYSE:GSK) and drug partner Human Genome Sciences (NASDAQ:HGSI), can now count Canada among the markets where it will offer the first new lupus treatment in nearly 50 years.

The companies on Tuesday announced that Health Canada has approved Benlysta. People with lupus in Canada can expect to see the drug available to them  in September. London-based GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina, and Maryland company Human Genome Sciences received U.S. Food and Drug Administration approval for Benlysta in March. Their partnership on Benlysta R&D dates to 2006 though their collaborative relationship extends back into the 1990s.

Lupus is an autoimmune disease in which the body attacks its own tissues and affects the organs. Pain and inflammation typically result, as well as extreme fatigue, unexplained fever, skin rashes and kidney problems. The disease affects women more than men and it is more prevalent among patients of  black African heritage.

According to Lupus Canada, the disease affects about 1-in-1,000 people in Canada — nearly 34,000 Canadians. The Lupus Foundation of America estimates that 5 million people worldwide live with some form of the disease.  GSK and Human Genome Sciences are still awaiting Benlysta’s approval by European regulators.

Here is what the Lupus Foundation has said about Benlysta, which includes the group’s explanation that as much of a medical breakthrough that the drug represents,  it  does not work for all lupus patients.