Rockville-based Human Genome Sciences Announces European Approval of Lupus Drug

Benlysta—a lupus drug developed by Rockville-based and GlaxoSmithKline PLC—has been approved for use in Europe, the companies announced Thursday.

The announcement follows Monday’s announcement by the companies that the drug—the first for the treatment of lupus in more than 50 years—had been approved for use in Canada.

Lupus is an inflammatory disease in which antibodies in the immune system attack joints, skin, the kidneys, the lungs, the heart and even the brain.

Its approval is pending in Australia, Switzerland, Russia, Brazil, The Philippines, Israel, Singapore, Taiwan and Colombia.

“We and GSK are committed to making Benlysta available in countries worldwide,” HGS President and Chief Executive Officer H. Thomas Watkins said in a statement. “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.”

Thomson Reuters consensus forecasts predict that global sales of the drug could top $3 billion in 2015, Reuters reported.

Clinical studies are ongoing. Benlysta has been effective in treating skin and joint disease, though it has yet to be proven beneficial to African Americans or in treating kidney disease. Doctors and lupus patients are hopeful that it could be effective in treating yet-to-be-determined diseases.

When the FDA approved the drug in March, state and county elected officials and business leaders hailed the development as a sign that the county’s investment in biotech is paying off.