New Lupus Drug Heads to FDA for Approval

An experimental lupus drug has just met another key goal in its journey to becoming the first approved treatment for the disease in over 50 years. The target of the new drug, known as Benlysta, is to suppress the response of the body’s immune system to lupus in an attempt to control the actions of a protein that becomes overactive in lupus patients.

Hopes were that the study data from a clinical program called Bliss-76 would confirm the optimistic results of a prior late-stage study. In actuality, the indications of the Bliss-76 data were that a 10-milligram dose of Benlysta, accompanied by therapy with steroids, resulted in improvement among 43 percent of lupus patients taking a higher dose, as well as a 40.6 percent of those taking a lower dose. This is compared to improvements observed in only 33.8 percent of patients taking a placebo.

Makers of the drug, Human Genome Sciences (HGS) based in Rockville, Maryland, and GlaxoSmithKline based in the United Kingdom, now plan to seek the regulatory approval of the U.S. Food and Drug Administration in the early months of 2010. If approved, Benlysta could be available on the market by late next year.

In a statement, HGS President and CEO H. Thomas Watkins said, “The Bliss-76 results confirm our view that Benlysta has the potential to become the first new approved drug in decades for people living with systemic lupus.” He then added, “We take great pride in the innovation and scientific rigor that has made it possible to bring Benlysta to this point.”

The Bliss-76 study was the second of two late-stage studies, and involved 865 patients who were treated and monitored over a period of one year. In October of this year, the first late-stage study, called Bliss-52, involved over 800 patients in Asia, South America and Eastern Europe, and has positive results in meeting several key goals.

Lupus is an inflammatory, autoimmune condition, in which the body’s defense system against pathogens attacks the body’s own tissue causing health issues such as rashes, mouth sores, arthritis, and kidney damage among other problems. Because the illness manifests itself differently in each patient, it is difficult to develop effective treatments against the disease. According to Watkins, “We’ve got a good chance to redefine the standard of care for patients living with lupus.”

While one recent study estimated that 322,000 Americans most likely have the most common form of lupus known as systemic lupus erythematosus, the Lupus Foundation of America estimates that about 1.5 million Americans have some form of the disease. According to Sandra C. Raymond, the organization's president and chief executive, “Individuals with lupus and their families have waited more than 50 years to hear that it is possible to develop therapies that control the disease.” She went on to say, “We believe that this is a significant first step in developing the full arsenal of therapies and personalized treatment lupus requires.”