The first treatment developed for lupus in over 50 years has finally been approved by the European Union this week. The watchdog, European Medicines Agency, has backed the injectable drug that will cost Europeans $23,000 USD a year. Already approved in the United States in March 2011, the drug costs Americans $35,000 USD annually.

Benlysta’s annual global sales are expected to reach $3.55 billion in 2015, according to Thomson Reuters Pharma consensus forecasts. Some analysts predict sales as high as $5 billion in later years. GlaxoSmithKline (GSK) will share profits with discovery partner Human Genome Sciences. Other regulatory applications are under review in Canada, Australia, Switzerland, Russia, Brazil, the Philippines, Israel and Colombia.

The disease affects many parts of the body including the joints, the skin, kidneys, lungs, heart, and the brain. When common lupus symptoms appear (flare) they can present as swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss, and fatigue.

Estimates vary on the number of lupus sufferers in the United States ranging from approximately 300,000 to 1.5 million people. People of all races can have the disease; however, African American women have a 3 times higher incidence (number of new cases) than Caucasian women.

Benlysta is the first drug of its kind that is designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus. B lymphocyte stimulator (BLyS), a soluble ligand of the TNF cytokine family, is a prominent factor in B cell differentiation, homeostasis, and selection. BLyS levels affect survival signals and selective apoptosis of autoantibody-producing B cells. High levels of BLyS may relax B cell selection and contribute to autoantibody production, exacerbating the SLE disease state.

Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines. Results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares, and some reduced their steroid doses.

A company funded study showed 43% of patients given a high Benlysta dose with standard therapies felt relief, and had no further organ damage after one year of treatment in comparison with nearly 34% with a placebo and standard therapies, which typically include immunosuppressant drugs.

When the drug was approved in the U.S. in March, Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA), issued the following statement regarding the FDA’s decision:

“This is a historic day for the millions of people with lupus and their families around the world who have waited more than 50 years for a treatment breakthrough for lupus. We at the LFA applaud the FDA’s decision to approve Benlysta. Benlysta is the first drug ever to be specifically developed to treat lupus, and is a significant first step toward reaching our goal of developing an arsenal of new, safe, effective, and tolerable treatments. Today marks the beginning of a new era of improved diagnosis, prevention, and treatment for the disease.”

Sources: The U.S. Food and Drug Administration, The Lupus Foundation and The European Medicines Agency

Written by Sy Kraft