FDA Approves First New Drug for Lupus in a Half-Century

The Food and Drug Administration has approved the first new drug for the treatment of lupus in 56 years.

As the Los Angeles Times reports, Benlysta promises relief to some sufferers of the potentially fatal immune system disease, alleviating symptoms ranging from joint pain and fever to fatigue and rashes.

The Wall Street Journal noted that Benlysta is the first drug derived through genomics, the study of genes. It was developed by Human Genome Sciences, one of the pioneers of medical genome research.

The drug’s approval fueled hopes that genomic drug development will deliver a host of medical breakthroughs.

Previously, the most common treatment for lupus was the steroid prednisone, which has a number of troubling side effects, among them osteoporosis and diabetes.

While Belysta was approved on the strength of two clinical trials demonstrating its safety and effectiveness, the FDA also ordered further studies to evaluate why it showed no benefits for African-American or African patients. Officials said that the small number of trial participants coming from those two groups may be behind the discrepancy.

What’s more, even among the full group of patients in the clinical trial, the drug’s impact was only marginal. As The New York Times pointed out, the FDA estimated that, for every 11 patients treated with Benlysta, only one benefits.

According to the FDA, up to 1.5 million Americans suffer from lupus, although estimates vary widely. African-Americans are disproportionately affected.

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