Lupus drug offers 1.5 million hope

By Sheilah Downey (sheilahd@foodconsumer.org)

After a 50-year dry spell in new Lupus treatment, two pharmaceutical companies today announced positive test results on their drug Benlysta to treat the complex, debilitating and sometimes fatal disease.

"For people with lupus and their loved ones, this is an historic day!" announced Sandra C. Raymond, executive officer of the Lupus Foundation of America (LFA) in a press release.

Results of the year long, international study were announced by Human Genome Sciences and GlaxoSmithKline who saw their stock prices soar 228 percent today from Friday's closing price.

The companies stated in a joint press release that while the first phase of tests was successful, the drug will undergo another clinical study in the fall before it can be approved by the Food and Drug Administration.

"The (study) results demonstrated that Benlysta has the potential to become the first new approved drug in decades for people living with systemic lupus," said H. Thomas Watkins, president and chief executive officer of Human Genome Sciences.

The Lupus Foundation said the results of the study concluded that patients who were treated with Benlysta had improvement in overall disease activity without significant flare-ups. Patients were also able to reduce their intake of steroids.
 
Watkins said the companies will continue with clinical trials in November and hope to submit marketing applications for its approval in the first half of 2010.

More than 5 million people worldwide have lupus, according to health estimates, with 1.5 million in the United States. Primarily a disease that affects young women between the ages of 15 to 40 years, lupus is a chronic inflammatory disease that occurs when the body's immune system attacks its own tissues and organs. Inflammation caused by lupus can affect the joints, skin, kidneys, blood cells, heart and lungs.

Lupus can also be fatal. According to a Centers for Disease Control study, more than 22,861 deaths occurred from lupus between 1979 and 1998, or about 1,400 people a year. During that same time, the death rates among black women with lupus between the ages of 45 to 64 years increased by 70 percent.