The Food and Drug Administration (FDA) approved Benlysta® (belimumab), a new biologic therapy developed to treat patients suffering from active, autoantibody-positive systemic lupus erythematosus (SLE). This landmark decision heralds the first new therapy developed and approved by the FDA specifically for lupus since 1955.
According to Virginia T. Ladd, President and Executive Director of the American Autoimmune Related Diseases Association (AARDA), “The FDA’s approval of Benlysta is momentous not only for the new hope it brings to the 300,000 to 1.5 million Americans suffering with lupus but also for the millions of Americans who suffer from many other autoimmune diseases such as autoimmune hemolytic anemia and autoimmune hepatitis. These diseases, along with lupus, have not seen the development of specific new treatments since the 1950s. Benlysta exemplifies a welcomed interest by today’s biotechnology and pharmaceutical companies to investigate and develop new treatments for orphan and less common diseases.”
Lupus is one of the 100+ diseases, all categorized as autoimmune, which share a common cause of autoimmunity. Autoimmunity is a result of a misdirected immune system that causes one’s own immune system to attack the self. Autoimmune diseases affect 50 million persons across the United States and affect women 75 percent more often than men. As a category, autoimmune diseases are one of the top 10 causes of death among women under the age of 65.
Ladd also noted that approval of Benlysta in March is particularly gratifying as it is National Autoimmune Diseases Awareness Month.
Awareness is a major barrier to the timely diagnosis of autoimmune diseases, primarily because most Americans have simply never heard of them. According to a study by AARDA, fewer than 13 percent of Americans can even name an autoimmune disease.
Source: American Autoimmune Related Diseases Association (AARDA)