First New Lupus Drug in 50 Years Wins FDA Approval

In what is being hailed as a hallmark in health care, the U.S. Food and Drug Administration has approved Benlysta, a medication designed for treatment of lupus erythematosus. Not only is Benlysta the first new drug for lupus in more than 50 years to reach the market, but it is the first drug derived from the study of genes (genomics), reports The Wall Street Journal. Lupus is an autoimmune disorder that affects nearly 1.5 million Americans, with women of all races nine times more likely than men to develop the disease. African Americans, Hispanics, Asians and Native Americans have a higher disease incidence than Caucasians. 

The development of Benlysta has been years in the making and is the product of a joint effort between Human Genome Sciences, Inc. and GlaxoSmithKline. To date, Benlysta is the first drug to be approved by the FDA that has been developed through the 20-year-old Human Genome Sciences company. 

A troubling fact is that the medication failed to show positive results for African American study participants. The FDA has requested and Human Genome Sciences has agreed to conduct a new study to ascertain treatment and safety outcome potentials for African Americans and those of African descent.